Earlier this month, U.S. House of Representatives Energy and Commerce Committee Chairman John Dingell (D-MI) and Oversight and Investigations Subcommittee Chairman Bart Stupak (D-MI) sent a letter to David M. Walker, Comptroller General of the U.S. Government Accountability Office (“GAO”) requesting that the Office update …
Last week, we reported on a January 16, 2008 proposed rule issued by FDA that would “reaffirm [the Agency’s] longstanding position that” labeling changes for approved drugs, biologics, and medical devices made by Changes Being Effected Supplements (“CBE Supplements”) may only be made to show …
On January 16, 2008, FDA issued a proposed rule that would “reaffirm [the Agency’s] longstanding position that” labeling changes for approved drugs, biologics, and medical devices may only be made to show newly acquired information or to “add or strengthen a contraindication, warning, precaution, or …
We previously reported on the new voluntary Direct-To-Consumer (“DTC”) television ad user fee program established by the FDA Amendments Act (“FDAAA”) and FDA’s establishment of Fiscal Year 2008 DTC television ad user fee rates. Due to inadequate funding by Congress, however, the new program will …
On January 8, 2008, the District of Columbia Council passed the SafeRx Act of 2007 (“Act”), which requires pharmaceutical detailers to be licensed by the Board of Pharmacy. The Act will be presented to Mayor Adrian Fenty for his signature and then to Congress if …
Earlier today, The Plain Dealer, a Cleveland newspaper, reported that Senator Sherrod Brown (D-OH) submitted a request to the Congressional Research Service (“CRS”) requesting information on FDA’s “Fast Track” designation program. CRS provides policy and legal analysis to committees and to Members of both the …
We previously reported on FDA’s plans to take enforcement action with respect to firms manufacturing and distributing unapproved drugs containing hydrocodone. According to the October 1, 2007 FDA Federal Register notice: Anyone marketing unapproved hydrocodone products that are currently labeled for use in children younger than …
Title VIII of the recently-enacted FDA Amendments Act (“FDAAA”) requires the responsible party of an applicable clinical trial (for both drugs and devices) to certify that the new requirements of Public Health Service Act (“PHS Act”) § 402(j) have been met. Under PHS Act § …
Earlier today, FDA issued a Federal Register notice announcing the Fiscal Year 2008 user fee rate for advisory review of Direct-to-Consumer (“DTC”) Television advertisements for prescription drug and biological products. The advisory review fee for FY2008 will be $41,390 for each proposed television advertisement voluntarily submitted …
Earlier this week, the European Medicines Agency (“EMEA”) announced that EMEA and FDA have adopted a common application form for sponsors seeking orphan drug designation in the European Union (“EU”) and the U.S. The move to a common application form was anticipated when FDA and …
In the preemption world, “fraud on the FDA” cases are fairly common. As one court recently used the term, fraud on the FDA means a drug or a medical device company is liable to someone who was injured by their product if that product was …
Late last week, FDA announced several steps intended to strengthen the advisory committee process. The announced improvements are part of a broader FDA effort to address recommendations made by the Institute of Medicine in its September 2006 report, titled "The Future of Drug Safety: Promoting …
Yesterday, Representatives Henry Waxman (D-CA) and Tom Allen (D-ME) and Senator Ted Kennedy (D-MA) announced plans to introduce the Non-Prescription Drug Modernization Act of 2007 (“NDMA”). The bill comes in the wake of recent concern over the use of Over-the-Counter (“OTC”) cough/cold drugs in children …
Title VI of the recently-enacted FDA Amendments Act (“FDAAA”) amended the FDC Act to establish a non-profit corporation whose purpose is to advance FDA’s Critical Path Initiative to “modernize medical, veterinary, food, food ingredient, and cosmetic product development, accelerate innovation, and enhance product safety.” (The …
The Department of Health and Human Services’ (“DHHS”) Office of Inspector General (“OIG”) recently announced its Fiscal Year 2008 Work Plan. The OIG Work Plan, issued annually, sets forth various projects to be addressed during the coming fiscal year by the Office of Counsel to …
