By Kurt R. Karst –      

In a Complaint lodged against the U.S. Patent and Trademark Office (“PTO”) in the U.S. District Court for the Eastern District of Virginia last September, but only recently served, the Genetics & IVF Institute (“GIVF”) is challenging the PTO’s August 2010 denial of a Patent Term Extension (“PTE”) for U.S. Patent No. 5,135,759 (“the ‘759 patent”), which covers a method to preselect the sex of offspring.  The patent is for a medical device for sperm sorting apparatus that is the subject of a Premarket Approval application (“PMA”) undergoing FDA review.  The ‘759 patent is owned by the U.S. Department of Agriculture (“USDA”) and is exclusively licensed to GIVF.

Under the PTE statute at 35 U.S.C. § 156(d)(5)(A), the PTO may grant an interim patent extension while a PMA is undergoing FDA review if the patent owner (or his agent) “reasonably expects that the applicable regulatory review period . . . that began for a product that is the subject of such patent may extend beyond the expiration of the patent term in effect.”  To request an initial interim PTE, the owner (or his agent) submits an application to the PTO “during the period beginning 6 months, and ending 15 days before such term is due to expire.”  The statute provides that a total of 5 interim PTEs may be granted.  After the initial interim PTE is granted, 35 U.S.C. § 156(d)(5)(C) provides that “[e]ach such subsequent application shall be made during the period beginning 60 days before, and ending 30 days before, the expiration of the preceding interim extension” (emphasis added).

The 17-year term of the ‘759 patent was set to expire on August 4, 2009; however, the USDA requested, and the PTO granted, an interim PTE for a period of one year, through August 4, 2010.  Just days before the interim PTE was going to expire, the USDA, on July 27, 2010 petitioned the PTO under 37 C.F.R. §§ 1.182 and 1.183 for an extension of time to file a second interim PTE and also a request for a second subsequent interim PTE.  Sections 1.182 and 1.183 relate to mechanisms for persons to file petitions to seek waiver of a rule or relief from the enforcement of a rule.  The USDA argues in its petition, among other things, that the language, structure, and purpose of the PTE statute give the PTO discretion to grant a second subsequent interim PTE outside of the timing window of 35 U.S.C. § 156(d)(5)(C).  In particular, the USDA argues that the PTE statute at 35 U.S.C. § 156(a) states that a PTE “shall” be granted provided certain conditions are met, and the USPTO’s implementing regulation at 37 C.F.R. § 1.720(a) uses the word “may.”  Thus, according to the USDA, if the word “shall” means “may” to the PTO for purposes of 35 U.S.C. § 156(a), then the word “shall” in 35 U.S.C. § 156(d)(5)(C) should also mean “may,” and the PTO has discretion to grant the USDA’s untimely request for a second subsequent interim PTE for the ‘759 patent.

The PTO was unconvinced and on August 2, 2010 denied both the USDA’s petition and request for a second subsequent interim PTE. 

As an initial matter, the PTO ruled that 37 C.F.R. §§ 1.182 and 1.183 do not permit an extension of the time period to request a second subsequent interim PTE.  “Because the relief that petitioner seeks is from a statute, the USPTO, without any statutory authority to grant such relief, cannot excuse failure to comply with the statutory timing requirement of § 156(d)(5)(C), and thus must deny the petition under 37 C.F.R. § 1.182,” states the PTO in its ruling.  Similarly, with respect to the USDA’s petition under 37 C.F.R. § 1.183, the PTO ruled that “Petitioner’s situation is controlled by statute, thus, there is no rule which can be waived which would provide sufficient relief.”

With respect to the meaning of the word “shall” in the PTE statute, the PTO states that as a general matter “the best definition of ‘shall’ as used throughout section 156 indicates an imperative duty based upon the text, structure, and purpose of the statute.”  Moreover, the USDA’s “shall/may” argument is misplaced, according to the PTO:

Petitioner’s argument fails to appreciate the “if” at the end of the introduction to 37 C.F.R. § 1.720(a).  Specifically, the rule states, “[t]he term of a patent may be extended if.”  The use of “if” in the rule language serves to require certain information in order for the Director to have authority to issue an extension.  Thus, the “may” to which petitioner refers, when read in conjunction with the “if” of the phrase, actually means “may only.”  In essence, the USPTO may only grant a patent term extension if certain conditions are met.  Because the USPTO may only grant a patent term extension is certain conditions are met, the “may . . . if” of 37 C.F.R. § 1.720 has the effect of requiring a timely filing, i.e. “shall.”  The USPTO’s use of “may . . . if” does not mean that the USPTO is departing from “shall.” [(Emphasis in original)]

GIVF, as the exclusive licensee of the now-expired ‘759 patent, sued the PTO under the Administrative Procedure Act, and asks the court to, among other things, vacate and set aside the PTO’s August 2nd decision and to declare that the PTO has the discretion to extend the term of the ‘759 patent for the full period required under 35 U.S.C. § 156.  The arguments in GIVF’s Complaint echo some of those made by the USDA in its petition and request for a second subsequent interim PTE.  In particular, GIVF argues that:

The language, structure, and purpose of § 156 give the USPTO discretion to authorize a second interim [PTE] sought outside the statutory window.  Though § 156 states that “[t]he term of a patent . . . shall be extended” as long as certain criteria are met, .the regulations promulgated pursuant to this statute do not use the word “shall.”  Instead, they list the same statutory criteria, and state that the [sic] “[t]he term of a patent may be extended.” [(Internal citations omitted)] 

And pulling the U.S. District Court for the Eastern District of Virginia’s March 2010 decision (and later August 2010 decision) concerning a late-filed PTE application for ANGIOMAX out of it’s back pocked, GIVF notes that:

Indeed, this Court recently recognized in a similar matter that “[t]here is a strong presumption that when Congress repeats the same word in the same statute, it intends for that word to be given the same meaning.”  If the word “shall” in § 156(a) means “may” as the USPTO seems to indicate in its own regulations, then that word should have the same meaning in § 156(d)(5)(C) as well.  Given the permissive, discretionary nature of the word “shall” in § 156, it stands to reason that the USPTO has the discretion to approve USDA’s petition for a second interim [PTE]. [(Internal citation omitted)]

GIVF also takes issue with the PTO’s decision that 37 C.F.R. §§ 1.182 and 1.183 do not permit an extension of the time period to request a second subsequent interim PTE.  According to GIVF, both sections provide the PTO with ample discretion to remedy the USDA’s “mild tardiness” in untimely requesting a second subsequent interim PTE.

Hyman, Phelps & McNamara, P.C.'s Jeff Shapiro published an article in this month's MD&DI magazine -  What Happens to Medical Device Reports Once They Reach FDA?  In the article, he summarizes a Office of Inspector General Report finding that FDA has not used medical device reporting ("MDR") data to improve medical device safety.  He suggests that eliminating malfunction MDRs would significantly reduce the burden on industry and FDA, and would allow FDA to better focus on device problems that cause actual serious injuries or deaths.

By Ricardo Carvajal –

The American Bar Association’s Section of Ligation (specifically the Food and Supplements Subcommittee of the Products Liability Committee) is presenting its First Annual Workshop on Food and Supplements on February 17 in Atlanta.  Hyman, Phelps & McNamara, P.C.’s Ricardo Carvajal will be co-moderator for a session on the impact of the Food Safety Modernization Act and other reforms on the food industry.  The program will also address state consumer laws and class actions related to packaging, labeling, and marketing; the evolving science of food safety and technology; ethical considerations in the labeling of biologically active foods; and predictions for the future of food labeling and regulation.  A brochure with additional information is available here and on-line registration is available here.

By Kurt R. Karst –      

In a January 7th letter sent to FDA Commissioner Margaret Hamburg, a group of four U.S. Senators take exception to FDA’s recent characterization of the 12-year exclusivity period provided by the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”) as a period of “market exclusivity” instead of “data exclusivity.”  The Senators also take the opportunity to remind FDA that the BPCIA allows for a separate period of exclusivity for new biological products. 

The letter, signed by Senators Kay Hagan (D-NC), Orrin Hatch (R-UT), Michael Enzi (R-WY), and John Kerry (D-MA), raises the same two issues some House members – the principal authors of the BPCIA – raised in a December 2010 letter to FDA.  As we previously reported, the House letter notes “significant and critical differences between the two types of exclusivity” (i.e., data and market exclusivity) and says that while so-called “evergreening” is not permitted under the BPCIA, “if a ‘next generation’ product is approved by the FDA as a new product (significant changes in safety, purity, or potency) then that new biologic will receive its own 12-year period of data exclusivity.” 

The January 7th Senate letter, which similarly seeks to clarify the exclusivity vernacular and to lay an early foundation for what are certain to be future battles over the availability and scope of the exclusivity period created by the BPCIA, states:

The [BPCIA] does not provide market exclusivity for innovator products.  It provides data exclusivity, which prohibits FDA from allowing another manufacturer of a highly similar biologic to rely on the Agency's prior finding of safety, purity and potency for the innovator product for a limited period of time.  It does not prohibit or prevent another manufacturer from developing its own data to justify FDA approval of a full biologics license application rather than an abbreviated application that relies on the prior approval of a reference product. . . . 

At the same time, the Act provides incentives for innovators to research and develop new treatments for patients.  If a manufacturer modifies an approved product to produce a change in safety, purity or potency, the modified product is rightly considered a new product.  It will be protected by the data exclusivity provisions afforded new products. Exclusivity on the first generation product will expire as scheduled.

For those of you who are interested in a further discussion of data versus market exclusivity, which folks have tussled over for years, our friend Steve Grossman over at FDA Matters had a nice post on the topic last year in the context of the BPCIA.

The BPCIA’s 12-year exclusivity period (which can be extended to 12.5 years with pediatric exclusivity) has been criticized from several quarters.  Late in 2010, Senator Bernie Sanders (I-VT) even said that the BPCIA’s 12-year exclusivity provisions create an ethical “defect” and should be changed.  (See our previous post here.) 

Taking a somewhat different position than Sen. Sanders on the topic of exclusivity are the authors of a recent article published in Health Affairs, titled “The Benefits From Giving Makers of Conventional ‘Small Molecule’ Drugs Longer Exclusivity Over Clinical Trial Data.”  The article details the results of a study (apparently the first of its kind, and funded by INTERPAT, “an association of research-based pharmaceutical companies,” and by the National Institute on Aging) intended to calculate the financial and social costs of limiting access to trial data.  The article focuses on small molecule drugs, which are subject to the Hatch-Waxman Amendment’s 5-year new chemical entity and 3-year new clinical investigation exclusivities, but asks whether a longer period of exclusivity, like the BPCIA’s 12-year period, would benefit innovation, population longevity, and social welfare.  Guess what?  According to the authors, extending data exclusivity to 12 years would (1) “increase lifetime drug revenues by 5 percent, on average;” (2) “result in 228 extra drug approvals between 2020 and 2060, relative to the number of approvals that we project under the current Hatch-Waxman data exclusivity provisions;” and (3) for people turning 55 in 2060, they “can expect increased life expectancy of 1.44 years as opposed to 1.30 years under the status quo.”

By David B. Clissold –

Last week, FDA released Agency's first guidance for tobacco product manufacturers concerning the introduction of “new” tobacco products.  The guidance was issued in final form since some manufacturers will need it to help them submit reports to FDA over the next few months.

A “new tobacco product” is a product that was not sold in the U.S. before February 15, 2007.  Any change made to a tobacco product after that date also makes it a “new tobacco product.”  In general, a tobacco product manufacturer must obtain an order after review of a premarket application under section 910(c)(1)(A)(i) of the Federal Food, Drug, and Cosmetic Act (“the Act”) before the manufacturer may introduce a “new tobacco product.”  Such an order is not required, however, if a manufacturer submits a report under section 905(j) of the Act for the new tobacco product (a “905(j) report”) and FDA issues an order finding that the tobacco product is (1) “substantially equivalent” to a tobacco product commercially marketed in the United States prior to February 15, 2007 or to a product found to be “substantially equivalent” to such a product (the “predicate tobacco product”), and (2) in compliance with the requirements of the law.  The guidance describes the information manufacturers should submit in the 905(j) report in order for FDA to make a “substantial equivalence” determination.

According to this guidance, the 905(j) report should provide side-by-side quantitative and qualitative comparisons of the new tobacco product with the predicate tobacco product with respect to all product characteristics.  These include design features (components, subcomponents, specifications, etc.), a listing of ingredients (ingredient names, common names, the function of each ingredient, and the amount of each ingredient), a list of materials used, a description of the heating source used in the consumption of the finished tobacco product, an explanation of how the design, materials, ingredients, and heating source of the product are integrated to produce the final product, and a listing of “harmful and potentially harmful constituents.”  The Act requires that the manufacturer submit or make publicly available an “adequate summary of any health information related to the tobacco product” that must contain “detailed information regarding data concerning adverse health effects.”  FDA recommends that this summary be provided in the 905(j) report.

Although similar to the process used to introduce new medical devices under section 510(k) of the Act, there are some differences.  Medical devices may use more than one “predicate device” for purposes of showing substantial equivalence.  In contrast, only a single predicate tobacco product should be used for comparison purposes in a 905(j) report since “FDA believes that a meaningful scientific comparison intended to determine whether the characteristics of the products are the same or are different but present no different questions of public health cannot be made between a new tobacco product and multiple predicate products.”  In addition, FDA may request additional data needed to make a substantial equivalence determination for a tobacco product.  The additional data that may be requested for a tobacco product include consumer perception studies (data comparing consumer perceptions that could affect initiation, cessation, frequency of use, patterns of use, smoking behavior, and perceptions of harm or addictiveness), clinical data (data comparing the biomarkers of exposure and biomarkers of potential harm and human toxicity between the tobacco products), abuse liability data (animal and human studies), and toxicology data including studies to assess carcinogenic potential.

A 905(j) report must be submitted at least 90 days before marketing a tobacco product that was not marketed in the United States as of February 15, 2007.  For tobacco products first introduced after February 15, 2007, and before March 22, 2011, the manufacturer must submit the report no later than March 22, 2011, or the product will be deemed to be misbranded and adulterated.  If a 905(j) report is submitted before March 23, 2011, the tobacco product may continue to be marketed unless and until FDA issues an order that the tobacco product is not substantially equivalent to the predicate tobacco product.  If a manufacturer is not able to submit all the data and other information recommended in the guidance by the statutory deadline, FDA will permit manufacturers “who have acted diligently” in preparing their 905(j) reports “a reasonable amount of time to supplement their initial submissions.”

By Kurt R. Karst –      

Last Friday, 32 State Attorneys General filed an amicus brief with the U.S. Supreme Court asking the Court to grant the Petition for Writ of Certiorari filed last month by a group of drug purchasers in Louisiana Wholesale Drug Co., Inc., et al., v. Bayer AG, et al. (Case No. 10-762).  As we previously reported, the case centers around whether a patent settlement agreement (what opponents call “pay-for-delay” agreements or “reverse payments”) involving manufacturers of Ciprofloxacin HCl (CIPRO) is per se lawful under the Sherman Act. 

In September 2010, the U.S. Court of Appeals for the Second Circuit denied a Petition for Rehearing and Rehearing En Banc filed on behalf of certain drug purchasers in In Re Ciprofloxacin Hydrochloride Antitrust Litig., 604 F.3d 98 (2d Cir. 2010), that a panel of judges on the Court invited in their April 2010 decision affirming a 2005 decision by the U.S. District Court for the Eastern District of New York granting summary judgment for defendants (i.e., Ciprofloxacin HCl manufacturers).  The Second Circuit panel affirmed the district court decision because the Court believed its 2005 decision in In re Tamoxifen Citrate Antitrust Litig., 466 F.3d 187 (2d Cir. 2005), compelled it to do so.  According to the Court, “[s]ince Tamoxifen rejected antitrust challenges to reverse payments as a matter of law, we are bound to review the Cipro court’s rulings under the standard adopted in Tamoxifen.”  The drug purchasers, in their petition to the Supreme Court, say that the Court’s decision is necessary to resolve a 3-way circuit split over the proper standard for determining whether an exclusion payment violates the antitrust laws.

California Attorney General Kamala D. Harris, the lead on the amicus brief in support of the direct purchasers’ Petition, announced the submission of the brief late last Friday.  According to the State Attorneys General, “[a] surge in reverse payment agreements is threatening the existence of generic competition and the availability of affordable drugs to the states and their citizens.” 

Overturning [the] Tamoxifen and Cipro [decisions], and permitting broader antitrust scrutiny of reverse payments would reinforce Congressional intent underlying the Hatch-Waxman Act.  Doing so also would not undermine the courts’ general policy of promoting settlement. Without reverse payments, patent litigants can settle, as they did in the pre-Tamoxifen years, with licensed entry, in which the license terms are based on the strength of the patent rather than sharing of monopoly profits.  Reverse payments are not necessary to settle patent cases, and the payments “serve no obvious redeeming social purpose.”  State antitrust enforcers have a keen interest in ensuring that generic exclusion results from the strength of the patent rather than rivals’ common interest in eliminating competition and sharing the spoils at the consumers’ expense. [(Internal citation omitted)]

Joining California Attorney General Harris on the amicus brief are the Attorneys General from Arizona, Arkansas, Delaware, Florida, Hawaii, Idaho, Illinois, Iowa, Maine, Maryland, Massachusetts, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Mexico, North Carolina, Oklahoma, Ohio, Oregon, South Carolina, Tennessee, Texas, Utah, Vermont, Washington, West Virginia, and Wyoming.

UPDATE:

• A second amicus brief submitted by several public interest groups (Consumer Federation of America, Prescription Access Litigation LLC, U.S. PIRG, and the National Legislative Association on Prescription Drug Prices) also urges the U.S. Supreme Court to grant the Petition for Writ of Certiorari.  "Few competition problems are as critical as pay-for-delay settlements such as the one involving Cipro," say the amici.  "Four arguments, slavishly followed by the courts, have introduced the gravest mistakes: (1) settlements are beneficial, (2) patents are presumed valid, (3) reverse payments fall within the scope of the patent, and (4) reverse-payment settlements are a natural by-product of the Act.  Strict adherence to these arguments flies in the face of the Hatch-Waxman Act and unnecessarily increases price and jeopardizes patients’ health."

By Susan J. Matthees –

Last week, FDA announced that the Agency has adopted final amended informed consent regulations.  As we noted last year, the Food and Drug Administration Amendments Act ("FDAAA") § 801(b)(3)(A) required that FDA amend the informed consent regulations set forth at 21 C.F.R. § 50.25 to include a statement to inform potential clinical trial participants that data from the trial has been or will be entered into a databank accessible to the public via www.clinicaltrials.gov.  FDA published the proposed rule implementing the FDAAA requirement in December 2009, and after considering comments, adopted the final rule, which will become effective on March 7, 2011.  However, FDA is providing a grace-period of 1 year, stating that the Agency intends to enforce the rule only for informed consent documents that are initiated on or after March 7, 2012. 

The statement that is required by amended 21 C.F.R. § 50.25 reads: “A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law.  This Website will not include information that can identify you.  At most, the Website will include a summary of the results.  You can search this Website at any time.”

Of note, FDAAA § 801(b)(3)(A) amends FDC Act § 505(i), which applies to drugs, so facially, it would appear that the new informed consent statement would only apply to drug trials.  However, FDA stated that because 21 C.F.R. Part 50 is one of the implementing regulations for FDC Act § 505(i), and 21 C.F.R. Part 50 applies to drugs and devices, FDA is applying the new informed consent language for drug and device trials.  FDA further explained that this will help maintain a uniform system for human subject protection and prevent confusion. 

Also interesting to note is that it is the investigator’s responsibility to obtain informed consent from research subjects.  21 C.F.R. § 50.20.  However, it is typically the responsibility of the sponsor of an applicable clinical trial to post the information to www.clinicaltrials.gov. 

By James R. Phelps –

California's SB 657, adopted in 2010, enlists manufacturers and retailers of goods with annual worldwide gross receipts over $100 million in the effort to eradicate “slavery and human trafficking.”  They are to provide information on their website to detail what they do to 1) verify that their chain of supply is not tainted with such practices, 2) conduct audits of suppliers to confirm lack of such involvement, 3) require direct suppliers to certify that materials used in products are complying with laws concerning slavery and human trafficking, 4) maintain accountability standards for employees and suppliers who fail to comply, and 5) provide employees involved in supply chain management with training about the slavery and human trafficking issues and how to mitigate their risks in the businesses.  Failure to comply, the law says, may subject the business to injunction actions brought by the state’s attorney general.  Presumably, this would apply to most manufacturers of food, drugs, and medical devices that purchase raw materials or components from overseas sources.

Some national governments that are U.S. trade partners are not so punctilious about the rights of workers.  In some of those jurisdictions people are told where they will work, without regard to the individuals’ wishes; how should those doing business in California react to these situations?  What would be the effect, should the businesses identify those jurisdictions in their websites?  How will they, in order to provide correct information on the website, police the compliance of suppliers from those jurisdictions?  There are other practical issues that need no elaboration.

It is admirable that the California legislature, with so many grave issues before it, is able to find the time and energy to address the international blight of slavery and human trafficking.  The wisdom of directing California businesses to take the lead in solving the problem is yet to be determined.

Thanks to lawyer/lobbyist Randy Pollack for alerting us to this new law = Randy@Pollacklaw.com, (916) 448-4848.

By Kurt R. Karst –      

In a notice slated for publication in the January 7th Federal Register, FDA is seeking to end the continued marketing of many unapproved oral prescription drugs for the relief of cough, cold, or allergy.  The action will likely affect hundreds of marketed unapproved drug products evaluated under the Drug Efficacy Study Implementation (“DESI”) program –  including any Identical, Related, or Similar (“IRS”) product – that have been marketed for decades on the basis that such products are somehow shielded from obtaining approval of a marketing application.  (For background on DESI see the article here.)

FDA’s notice is broken down into two categories: (1) DESI cough, cold, or allergy dockets for which hearing requests have been withdrawn; and (2) DESI cough, cold, or allergy dockets with outstanding hearing requests.  The first category includes specific drug products identified in certain DESI proceedings noted in Docket Nos. FDA-1981-N-0361 (formerly 1981N-0391), FDA-1982-N-0225 (formerly 1982N-0078), FDA-1982-N-0310 (formerly 1982N-0311), including products IRS to them, for which all outstanding requests in response to a notice of opportunity for hearing have been withdrawn.  “Shipment in interstate commerce of the products identified in those dockets, or any [IRS] product that is not the subject of an approved new drug application (other than an over-the-counter (OTC) product that complies with an applicable OTC monograph), is unlawful as of the effective date of this notice,” FDA states in the notice.  The second category includes drug products identified in certain DESI proceedings noted in Docket Nos. FDA-1981-N-0077 (formerly 1981N-0393), FDA-1981-N-0248 (formerly 1981N-0396), FDA-1982-N-0046 (formerly 1982N-0095), FDA-1982-N-0264 (formerly 1982N-0096), and FDA-1983-N-0137 (formerly 1983N-0095), including products IRS to them.  For the drug products identified in these dockets, FDA is offering an opportunity for firms to affirm outstanding hearing requests.  “FDA will assume that companies with outstanding hearing requests that do not respond to this notice are no longer interested in pursuing their requests, and will deem the requests withdrawn,” according to FDA. 

FDA also states in the notice the Agency plans to take swift enforcement action against companies that continue to market unapproved drug products subject to the Federal Register notice.  “Firms should be aware that, after the effective date of this notice, FDA intends to take enforcement action without further notice against any firm that manufactures or ships in interstate commerce any unapproved product covered by this notice that is not the subject of an ongoing DESI proceeding.”  Although some of the drug products identified by FDA and marketed with well-known brand names might be able to be reformulated to comply with an OTC drug monograph, FDA cautions against firms using the same brand name, or a new brand name that is substantially the same as the brand name.  “Reformulated products marketed under a name previously identified with a different active ingredient or combination of active ingredients have the potential to confuse health care practitioners and harm patients.”

By Riëtte van Laack –

More than 9 years after issuing a proposed rule, the Food Safety and Inspection Service (“FSIS”) published the final rule for nutrition labeling of single-ingredient meat and poultry products, as well as ground and chopped meat and poultry products.  Starting January 1, 2012 (FSIS’s uniform compliance date for new food labeling regulations issued between January 1, 2009, and December 31, 2010), major cuts of single-ingredient, raw meat and poultry products are required to carry nutritional information on labels or at point-of-purchase (“POP”).  All raw ground and chopped meat and poultry products, with or without seasoning, must carry nutrition labels. 

The new rule allows POP nutritional information for major cuts because the nutrient content of a major cut is relatively uniform and because consumers can generally estimate the fat content in major cuts.  Thus, consumers can easily find the applicable information for the cut.  Manufacturers need not perform any analyses to determine the nutrient content of the major cuts, but may use data from USDA’s National Nutrient Data Bank or the USDA’s National Nutrient Database for Standard Reference.  FSIS will use these same data to determine compliance with the regulations.  No nutritional information is required for non-major cuts of single-ingredient, raw meat and poultry products. However, if a manufacturer voluntarily provides nutritional information for these products, then they must comply with the regulation for the major cuts.
 
In contrast, raw ground and chopped products, such as hamburger, ground beef, ground beef patties, ground chicken, ground turkey, chicken, ground pork, and ground lamb must carry a nutritional label on the package.  Producers can precisely formulate these products to a specific fat content.  The fat is uniformly distributed throughout the ground product making it difficult for consumers to determine and compare the level of fat in these products.   POP nutritional information is not a viable alternative because there are numerous formulations of ground and chopped products; it would be difficult if not impossible for producers or retailers to develop POP materials that address all different formulations. Moreover, if POP nutritional information were provided, it would be difficult for consumers to find the correct information for a specific ground or chopped product. 

The nutritional information to be provided under the regulation is similar to that required by FDA for other foods.  However, unlike FDA, FSIS does not require labeling of trans fat content.  In addition, because raw meat products typically have random weights, the regulations do not require inclusion of the number of servings per container.

Numerous exemptions apply, including an exemption for ground or chopped products that qualify for the small business exemption, i.e., products produced by a facility that employs less than 500 people and produces no more than 100,000 lbs per year of a particular product. Note, however, that the small business exemption does not apply to nutritional labeling requirements for major cuts of single ingredient raw meat and poultry products because it is relatively easy to prepare point-of-purchase materials for these products. Moreover, FSIS will make POP materials available over the internet free of charge.

FSIS intends to conduct webinars on the final rule.

By Ricardo Carvajal –

The Food Safety Modernization Act ("FSMA") is now law.  We previously blogged on some provisions that take immediate effect (namely stronger records access authority under FDC Act § 414, mandatory recall authority, whistleblower protection, and authority to refuse admission of imported food from a facility that refuses inspection).  Other provisions that enhance FDA’s existing authorities but will take time to implement include suspension of registration, lower threshold for administrative detention, and import certification. Still other provisions will impose or authorize FDA to impose significant ongoing burdens on industry, most notably mandatory HACCP and associated recordkeeping requirements, additional recordkeeping requirements for high risk foods, compliance with performance standards and produce safety standards, implementation of measures to protect against intentional adulteration, verification of foreign suppliers’ compliance with U.S. law, and payment of reinspection fees.  We plan to spotlight these provisions as their effective date draws nearer. 

For now, it’s worth revisiting an issue we raised with respect to the FSMA’s companion bill, the Food Safety Enhancement Act – namely that of burdens imposed on FDA.  The FSMA directs FDA to substantially increase the number and frequency of domestic and foreign inspections.  Further, by our estimate, the FSMA directs FDA to engage in 10 rulemakings, issue no fewer than 10 guidance documents, prepare 13 reports (some on a recurring basis), and engage in numerous other resource-intensive implementation activities.  The burdens that these directives will impose on multiple components within FDA should not be underestimated.  In the absence of commensurate funding, it seems likely that the law will not be fully implemented and that numerous other food-related agency initiatives could once again find themselves on the back burner.  This type of discrepancy between increased agency responsibilities and the level of funding needed to fulfill those responsibilities has been identified as a cause of under-performance at FDA, such that a coalition of consumer and professional groups and trade associations (including a number of food trade associations) joined forces in the Alliance for a Stronger FDA to pressure Congress for additional agency funding.  The need for adequate funding to implement FSMA has already been acknowledged by the FDA Commissioner in her statement on the FSMA’s significance.  Whether FDA can buck the promised trend toward less government spending in 2011 and beyond will be one story to watch.

By Kurt R. Karst –    

In a letter recently submitted to FDA by the three principal authors of the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”) – Representatives Anna Eshoo (D-CA), Jay Inslee (D-WA), and Joe Barton (R-TX) – the legislators take issue with FDA’s characterization of the 12-year exclusivity period provided by the law and seek to clarify Congressional intent on granting new 12-year exclusivity periods for “next generation” products.

The BPCIA amended the Public Health Service Act (“PHS Act”) to, among other things, create an approval pathway for biosimilar and interchangeable versions of reference products (so-called § 351(k) applications) and establish a 12-year exclusivity period for reference products.  Specifically, PHS Act § 351(k)(7) provides for a 12-year period of exclusivity from the date of first licensure of the reference product, during which approval of a § 351(k) application cannot be made effective.  PHS Act § 351(k)(7)(C) includes certain limits on obtaining 12-year exclusivity.  That provision states that the date of first licensure, and therefore the 12-year exclusivity period, does not apply to a license for or approval of:

(i) a supplement for the biological product that is the reference product; or

(ii) a subsequent application filed by the same sponsor or manufacturer of the biological product that is the reference product (or a licensor, predecessor in interest, or other related entity) for –

(I) a change (not including a modification to the structure of the biological product) that results in a new indication, route of administration, dosing schedule, dosage form, delivery system, delivery device, or strength; or

(II) a modification to the structure of the biological product that does not result in a change in safety, purity, or potency.

In October 2010, FDA issued a Federal Register notice announcing a two-day public hearing to obtain input on specific issues and challenges associated with the implementation of the BPCIA.  Among the myriad issues for which FDA sought public comment were two questions on exclusivity:

1. In light of the potential transfer of BLAs from one corporate entity to another and the complexities of corporate and business relationships, what factors should the agency consider in determining the types of related entities that may be ineligible for a period of 12-year exclusivity for a subsequent BLA?

2. What factors should the agency consider in determining whether a modification to the structure of the licensed reference biological product results in a change in safety, purity, or potency, such that a subsequent BLA may be eligible for a second 12-year period of marketing exclusivity?

The BPCIA’s principal authors, in their December 21, 2010 letter, felt compelled to address FDA’s characterization of the 12-year exclusivity period as a period of “marketing exclusivity” in the Agency’s meeting notice.  The BPCIA “does not provide ‘market exclusivity’ for innovator products,” according to the letter.  “Rather, it provides data exclusivity for 12 years from the date of FDA approval . . . .”  The letter goes on to note the “significant and critical differences between the two types of exclusivity.”  “Data exclusivity only prohibits the FDA from allowing another manufacturer to rely on the data of an innovator to support approval of another product.  Importantly, it does not prohibit or prevent another manufacturer from developing its own data to justify FDA approval of a similar of competitive product.” 

The second issue raised in the letter concerns so-called “evergreening.”  Evergreening, which is the practice of obtaining additional periods of exclusivity for product modifications, was hotly debated during consideration of what ultimately became the BPCIA.  One legislative proposal even included an express prohibition on evergreening, and the Obama Administration’s 2009 10-year budget proposal raised concern about the practice.  PHS Act § 351(k)(7)(C) is intended to prevent evergreening by excluding most product changes from qualifying for a new 12-year exclusivity period.  

According to the December 21st letter, the BPCIA “is clear that no product, under any circumstances, can be granted ‘bonus’ years of data exclusivity for mere improvements on a product.”  Nevertheless, the legislators “want to be clear that if a ‘next generation’ product is approved by the FDA as a new product (significant changes in safety, purity, or potency) then that new biologic will receive its own 12-year period of data exclusivity.”  “Any proposal to limit the definition of a ‘new’ product, and thus one which is entitled to its own period of data exclusivity has the potential to stifle innovation and negatively impact patient care,” according to the letter. 

The scope the 12-year exclusivity period provided by the BPCIA is also discussed in lengthy comments (here and here) submitted to FDA by the Pharmaceutical Research and Manufacturers of America (“PhRMA”) and the Biotechnology Industry Organization (“BIO”).  Both PhRMA and BIO request that FDA apply the concept of “umbrella exclusivity” to new BLAs and BLA supplements that do not independently qualify for the 12-year exclusivity period. 

Under FDA’s “umbrella policy” for drug products, any remaining 5-year New Chemical Entity (“NCE”) exclusivity period granted under the Hatch-Waxman Amendments for the original NDA NCE approval applies to subsequent applications (both new NDAs and NDA supplements) for drug products containing that NCE until the NCE term expires.  According to BIO:

[I]it is important for FDA to clarify that BLA supplements and full BLAs that may not themselves be eligible for 12 years of exclusivity because they seek certain non-qualifying changes to already-approved products will nevertheless benefit from any remaining exclusivity for the underlying, previously-approved biologic.

PhRMA contends that any decision by FDA apply the Agency’s “umbrella policy” to BPCIA exclusivity would mean that: “(1) a supplement or subsequent application that was not entitled to its own 12-year period would be protected for any remaining period of exclusivity applicable to the first licensed product to which it is related, and (2) an affiliate or related entity’s product that was not entitled to its own 12-year period would be protected for any remaining period of exclusivity applicable to the initial applicant’s product.”  “Any other approach,” according to PhRMA, “would be inconsistent with [FDA’s] longstanding approach to data exclusivity [and] would seriously undermine the value of exclusivity and incentives to innovate.”

Hyman, Phelps & McNamara, P.C. (“HPM”) is pleased to announce that Anne K. Walsh has joined the firm as Of Counsel.  Prior to joining the firm in January 2011, Ms. Walsh served as an Associate Chief Counsel with the U.S. Food and Drug Administration’s Office of Chief Counsel from 2004 to 2010.  She worked closely with federal prosecutors and law enforcement agencies to investigate, negotiate, and litigate civil and criminal violations of the Federal Food, Drug, and Cosmetic Act.  Ms. Walsh has extensive knowledge of issues concerning health care fraud, off-label promotion, cGMP and reporting regulations, and clinical study fraud, as it relates to both corporate and individual liability.  She has won numerous awards for her work in groundbreaking prosecutions and settlements, including cases involving pharmaceutical, medical device, and in vitro diagnostics companies.  She also has experience advising on matters involving other FDA enforcement activities, including for-cause inspections, warning letters, and recalls. 

Ms. Walsh graduated from the College of William and Mary in 1994 with a B.A. in economics, and with a J.D. in 1997.  She is admitted to practice law in New York and the District of Columbia.  After graduating from law school, Ms. Walsh worked as an attorney in private practice representing major pharmaceutical and medical device clients. 

By Jeffrey K. Shapiro –

A group of nine U.S. Senators has sent a letter to FDA expressing concern over potential changes to the 510(k) medical device clearance program.  The letter is similar to a November 2010 letter from Minnesota lawmakers and an October 2010 letter from House lawmakers (see our previous posts here and here).  Each letter takes issue with FDA’s August 2010 report recommending changes to the 510(k) program, which we reported on last year. 

The Senatorial letter points to several “controversial” recommendations that “have the potential to disrupt the current regulatory balance under the 510(k) pathway, jeopardizing patients' timely access to new treatments and cures.”  In particular, the Senators “believe that the recommendations regarding rescission authority; split and multiple predicates; intended use and indications for use; splitting Class II; and the treatment of proprietary information, including trade secrets could have significant unintended adverse consequences on the existing regulatory process.”

By Diane B. McColl & Ricardo Carvajal –

On December 28th, FDA reopened the public comment period for its 1997 proposed rule that outlined the voluntary GRAS notification process intended to replace the voluntary GRAS affirmation petition process.   FDA stopped accepting GRAS affirmation petitions and implemented the ongoing GRAS notification process when the 1997 proposed rule published.  According to the agency, publication of the December 28th  notice is the first step in FDA’s effort to at long last finalize the proposed rule.

FDA seeks comments not only on the 1997 proposal, but also on numerous issues raised by CFSAN's 13-year experience with the GRAS notification process for human foods, as well as some of the recent GAO recommendations (for our take on the GAO report, see here and here).  Because the notice raises several issues that were not explicitly addressed in the 1997 proposed rule, it should be carefully reviewed by anyone with an interest in FDA’s voluntary GRAS notification process, including those with long-pending GRAS affirmation petitions.  Note also that the agency requests input on issues relating to the GRAS notification process for animal feed and pet food ingredients newly implemented by CVM. Among the issues on which FDA requests comments:

• FDA’s proposed revisions to the regulation that states the eligibility criteria for GRAS classification (21 C.F.R. § 170.30);
• incorporation by reference of previously submitted data in a GRAS notice;
• requests to cease evaluation of a GRAS notice;
• inclusion in a GRAS notice of information claimed to be confidential;
• submission of specific descriptive information such as biological source, known toxicants, and particle size (the latter recommended by GAO due to concerns about nanotechnology)
  submission of information about dietary exposure;
• submission of species-specific information in the case of animal feed ingredients;
  coordination of FDA’s evaluations with USDA/FSIS;
• potential issuance by FDA of guidance on conflicts of interest among GRAS expert panelists (as recommended by GAO);
• potential issuance by FDA of additional guidance on documentation of GRAS conclusions (as recommended by GAO); and
• FDA’s disposition of pending GRAS affirmation petitions.

Any public comments submitted previously to FDA in response to the 1997 proposed rule need not be resubmitted.  New public comments are due by March 28, 2011.