By Kurt R. Karst – In a win for compounding pharmacies and a loss for FDA, the U.S. Court of Appeals for the Fifth Circuit ruled last week in Med. Ctr. Pharmacy v. Holder that the U.S. District Court for the Western District of Texas violated …
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Hyman Phelps McNamara
- Fifth Circuit Vacates District Court “Second Inspection Ruling” in Compounding Pharmacy CaseFebruary 28th, 2011
- FDA Determines that Homotaurine is Not a Dietary Ingredient, and Punts on Applicability of Its Rulemaking Authority Under FDC Act §§ 201(ff)(3)(B) and 301(ll)February 24th, 2011
By Ricardo Carvajal – FDA denied a citizen petition filed on behalf of OVOS Natural Health, Inc. (“OVOS”) that asked the agency to issue a regulation under FDC Act § 201(ff)(3)(B) or § 301(ll) acknowledging that marketing of homotaurine as a dietary ingredient in dietary supplements …
- The Itch is Scratched – FDA Denies XYZAL Carve-Out Petition; Another Precedent Added to the Generic Drug Labeling Carve-Out Citizen Petition ScorecardFebruary 24th, 2011
By Kurt R. Karst – It was just yesterday that we commented on how folks in the Hatch-Waxman community have been patiently awaiting FDA’s decision on an October 2010 citizen petition (Docket No. FDA-2010-P-0545) requesting that the Agency not approve any ANDA for a generic …
- Sen. Leahy Asks DOJ for Update on Investigation of Peanut Corporation of AmericaFebruary 23rd, 2011
By Ricardo Carvajal – In a letter directed to Attorney General Eric Holder, Senator Patrick Leahy (D-VT) asked the U.S. Department of Justice (“DOJ”) for an update on its investigation of the Peanut Corporation of America (“PCA”) and its president, Stewart Parnell. According to the letter, FDA …
- District Court’s Extension of 30-Month Stay on Generic XYZAL Approval Ends; ANDA Sponsors are Itching for an FDA Decision on “Carved-Out” Urticaria-Only LabelingFebruary 23rd, 2011
By Kurt R. Karst – As folks in the Hatch-Waxman community patiently await FDA’s decision on an October 2010 citizen petition (Docket No. FDA-2010-P-0545) requesting that the Agency not approve any ANDA for a generic version of XYZAL (levocetirizine dihydrochloride) with skinny labeling that omits, via …
- New Senate Legislation May Impede Voluntary Self-Enforcement by Companies Regulated by FDAFebruary 22nd, 2011
By Peter M. Jaensch – United States Senator Charles Schumer (D-NY) recently introduced legislation that is intended to prevent sales of recalled biologics, drugs, medical devices, infant formula, and foods. However, if that legislation is enacted it may actually dissuade companies from undertaking voluntary recalls. On February …
- Legislation to Ban Authorized Generics During 180-Day Exclusivity Period Makes a Comeback in CongressFebruary 21st, 2011
By Kurt R. Karst – Last week, substantively identical legislation was introduced in both the U.S. House of Representatives and in the U.S. Senate to amend the FDC Act to prohibit the manufacture, marketing, sale, or distribution of an authorized generic version of an NDA-approved drug …
- FDA Extends Compliance Period for Change in Enforcement Discretion Policy Concerning Phytosterol Health ClaimsFebruary 20th, 2011
By Riëtte van Laack – As previously reported, on Dec. 8, 2010, FDA published a proposal to amend the interim final rule ("IFR") governing health claims concerning the risk of cardiovascular heart disease and consumption of phytosterols (see 21 C.F.R. § 101.83). FDA stated that, as …
- FDA Sued Over E-Cigarettes – AgainFebruary 18th, 2011
By Ricardo Carvajal – Totally Wicked-E.Liquid (“TWI”), an importer and distributor of electronic cigarettes, filed suit to prevent FDA from regulating TWI’s electronic cigarettes as drugs, devices, or combination products, and from barring their importation into the U.S. TWI claims that the nicotine in its product …
- Just What the Doctor Ordered? A Number of States have Introduced Legislation to Require Prescriptions for all Pseudoephedrine ProductsFebruary 16th, 2011
By Peter M. Jaensch & John A. Gilbert – Since the passage of the federal Combat Methamphetamine Epidemic Act in 2005 and state legislation adopted in most states around the same time, retail sales of over-the-counter (“OTC”) cold and allergy products containing pseudoephedrine (“PSE”) have been subject to …
- The President’s FY 2012 Budget Would Create New User Fees, Ban Patent Settlements, and Reduce BPCIA Reference Product ExclusivityFebruary 15th, 2011
By Kurt R. Karst – The tome that is the President’s Budget for Fiscal Year 2012 is chock-full of new proposals that, if implemented, would significantly affect both brand-name and generic drug manufacturers. What first caught our attention were some statements in an overview of the proposed …
- Nothing New: FDA Announces its Innovation Pathway Program for Breakthrough TechnologiesFebruary 15th, 2011
By Jeffrey K. Shapiro – FDA’s Center for Devices and Radiological Health (“CDRH”) has proposed the “Innovation Pathway Program” for breakthrough medical devices. CDRH says it will review these products in 150 days or less, which the agency claims is nearly half the review time of …
- In Unusual Twist, FDA Warning Letter Cites Potential FTC Act ViolationsFebruary 14th, 2011
By Riëtte van Laack – Over the past two years, we have noted several joint or coordinated actions by FDA and FTC. The agencies issued their own warning letters to the same manufacturers at the same time (here and here), and, on several occasions, FDA and …
- Subsequent ANDA Sponsor Says DETROL LA Patent Has Gotta Go; But Would a Final Court Decision Trigger 180-Day Exclusivity?February 10th, 2011
By Kurt R. Karst – Late last year, Impax Laboratories, Inc. (“Impax”) filed a Complaint in the U.S. District Court for the District of New Jersey seeking a judgment with respect to U.S. Patent No. 6,911,217 (“the ‘217 patent”). The ‘217 patent is one of four …
- Inmates Sue FDA Over Importation of Death Penalty DrugFebruary 9th, 2011
By Susan J. Matthees – Six inmates on death row in three different states sued FDA in the U.S. District Court for the District of Columbia over the importation of thiopental sodium, one of the drugs used by some states to administer a lethal injection. The …