Hyman, Phelps & McNamara, P.C. today posted on its website an updated version of its outline entitled “Application of Health Care Fraud and Abuse Laws to Pharmaceutical Marketing." This 89-page outline, authored by Alan Kirschenbaum and Jeff Wasserstein, provides a comprehensive overview of how the …
By Anne Marie Murphy – We previously reported on the Consumer Product Safety Improvement Act of 2008 (“CPSIA”), which makes sweeping changes to the laws enforced by the Consumer Product Safety Commission (“CPSC”). CPSIA Section 102(a), paragraph (1), amends the Consumer Product Safety Act (“CPSA”) to require …
By Kurt R. Karst – As a follow-up to our recent post on obtaining orphan drug designation and approval based on a major contribution to patient care – the so-called “MC-to-PC” orphan drug designation and approval – we thought we would post on another rarity …
The latest issue of the Food and Drug Law Institute’s “Update” magazine features articles written by four Hyman, Phelps & McNamara, P.C. attorneys. The first article, titled “Imported Products – FDA Is Not Fooling Around,” was written by Dara Katcher Levy and John R. Fleder. It …
By Wes Siegner & Ricardo Carvajal – Last August, FDA published data that the Agency had gathered on the content of lead in 324 vitamin products labeled for use by women or children. FDA made clear that its estimates of lead exposures for all of …
By John A. Gilbert & Larry K. Houck – The Drug Enforcement Administration (“DEA”) has published advance notice of proposed rulemaking that solicits comments on the disposal of controlled substances by non-registrants. This proposal for the first time could authorize DEA registrants to accept controlled …
By Jamie K. Wolszon – On January 22, Senators Herb Kohl (D-WI) and Charles Grassley (R-IA) introduced the Physician Payments Sunshine Act of 2009, which would require drug, biologic, medical device, and other medical supply manufacturers to disclose to the Secretary of Health and Human …
By Diane B. McColl & Ricardo Carvajal – In an attempt to improve import safety and further implement its Food Protection Plan, FDA has issued a Guidance for Industry titled “Voluntary Third-Party Certification Programs for Foods and Feeds.” The guidance recognizes that independent certification of …
By Kurt R. Karst – Those following the subject of preemption of conflicting state laws have speculated for months whether the Obama Administration might undo the position FDA has advanced in Federal Register announcements and in court filings in which the Agency has generally staked …
By Diane B. McColl & Ricardo Carvajal – In response to a citizen petition filed on behalf of a pharmaceutical company, FDA has determined that products containing pyridoxamine (a form of vitamin B6) are not dietary supplements within the meaning of FDC Act § 201(ff) and …
By Riëtte van Laack & Ricardo Carvajal – On January 15, the Center for Veterinary Medicine ("CVM") published its final guidance on “Regulation of Genetically Engineered Animals Containing Heritable Recombinant DNA Constructs.” The final guidance describes CVM’s application of the FDC Act’s new animal drug provisions …
By Ricardo Carvajal – A report issued by Project on Emerging Nanotechnologies ("PEN"), a partnership between the Woodrow Wilson International Center for Scholars and the Pew Charitable Trusts, concludes that FDA is not prepared to effectively regulate dietary supplements that use “engineered nanomaterials” due to …
Ricardo Carvajal of Hyman, Phelps & McNamara, P.C. will be moderating panels or speaking in two upcoming conferences that address dietary supplement and food regulatory issues. The first is a Food and Drug Law Institute conference titled “What you Need to Know Now about Emerging …
By Ricardo Carvajal – FDA has issued a proposed rule that would amend the standard of identity for yogurt and revoke the regulations on standards of identity for lowfat and nonfat yogurt. Under § 401 of the FDC Act, FDA has the authority to establish a …
By Riëtte van Laack – On January 16, 2009, FDA announced the availability of its final guidance for industry, titled “Evidence-Based Review System for the Scientific Evaluation of Health Claims” (“2009 guidance”). At the same time, the Agency withdrew the 2003 “Guidance for Industry and …
