By William T. Koustas – In yet another twist in the debate regarding FDA’s use of Risk Evaluation and Mitigation Strategies (“REMS”), Kaiser Permanente (“Kaiser”), which is the largest private integrated health care delivery system in the U.S., submitted a citizen petition on December 22, …
By Alan M. Kirschenbaum – On January 5, 2010, FDA released a “Guidance for Industry on New Contrast Indication Considerations for Device and Approved Drug and Biological Products.” The primary purpose of the Guidance is to establish a process that allows imaging device manufacturers to …
By David B. Clissold – Acting on cross motions for summary judgment, a Federal District Court in Kentucky has struck down some provisions of the Family Smoking Prevention and Tobacco Control Act (“Tobacco Act”) as unconstitutional, and upheld others. As we had reported earlier, the …
By Kurt R. Karst – Following FDA’s decision, reflected in the October 2009 Orange Book Cumulative Supplement (page A-28), to grant 5-year New Chemical Entity Exclusivity (“NCE”) for EMEND (fosaprepitant dimeglumine) Injection, the Agency has issued an exclusivity determination explaining its decision. Fosaprepitant is a …
By Kurt R. Karst – A recent Impact Report (subscription required) from the Tufts Center for the Study of Drug Development (“CSDD”), titled “Drug approvals for neglected diseases increase along with more R&D funding,” concludes that new products to treat neglected diseases (such as malaria, …
By Ricardo Carvajal & David B. Clissold – The most recent issue of the Food and Drug Law Journal contains an article on the Family Smoking Prevention and Tobacco Control Act (“Tobacco Act”) authored by Hyman, Phelps & McNamara’s (“HPM’s”) Ricardo Carvajal, David B. Clissold, and …
Our colleague and friend, Stephen H. McNamara passed away on December 28, 2009 of complications from cancer at the age of 66. Steve is survived by Caroline, his wife of 43 years, and his children, Matthew (Veronica) McNamara, and Deborah (Nicholas) Hutchins and six grandchildren. Steve was …
By William T. Koustas – As FDA becomes more comfortable with the authority provided to it by the Food and Drug Administration Amendments Act of 2007 (“FDAAA”), the frequency of Risk Evaluation and Mitigation Strategies (“REMS”) being applied to an entire class of drugs is …
By Alan M. Kirschenbaum, Kurt R. Karst & J.P. Ellison – On Thursday morning, the U.S. Senate passed, by a 60-39 vote, H.R. 3590, the Patient Protection and Affordable Care Act. Last weekend, Sen. Harry Reid (D-NV) unveiled a 383-page Manager’s Amendment to the bill. …
By Nisha P. Shah – On December 8, 2009, the Food and Drug Administration ("FDA") issued its final, non-binding guidance for industry on “Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims.” A draft guidance was published in February 2006. The final …
By Carmelina G. Allis – Earlier this month, the United States Court of Appeals for the Second Circuit rendered a summary order affirming the District Court’s judgment for dismissal of the case. We previously reported that FDA had moved to dismiss HiFi DNA Tech, LLC’s (“HiFi’s”) …
By Michelle L. Butler – The Consumer Product Safety Commission (“CPSC” or “Commission”) has now voted to lift the stay of the testing and certification requirements for certain products and extend the stay for others. The Commission issued a press release last Friday regarding the decision, …
By Riëtte van Laack– Earlier this month, a citizen petition was submitted to FDA requesting that the Agency issue an order confirming that prescription prenatal vitamins containing 1-4 mg folic acid, either alone or in combination with other vitamins and minerals, and used to reduce the …
By Kurt R. Karst – A recent decision from the U.S. District Court for the Northern District of Illinois (Eastern Division) presents an interesting solution to a concern about the forfeiture of 180-day exclusivity when a company submits an ANDA containing both a Paragraph IV Certification …
By Michelle L. Butler – On December 16, 2009, the Consumer Product Safety Commission (“CPSC” or “Commission”) posted on its website a draft Federal Register notice that would announce the Commission’s decision to revise the terms of its stay of enforcement of certain testing and …
