In April 2007, we reported on a complaint filed by a group of non-profit organizations (including the Association of American Physicians & Surgeons, Concerned Women for America, Family Research Council, and Safe Drugs For Women) against FDA (and later Duramed Pharmaceuticals, Inc.) in the U.S. …
On February 29, 2008, Judge Stadtmueller of the United States District Court for the Eastern District of Wisconsin dismissed a lawsuit brought by Schering-Plough Healthcare Products, Inc. (“Schering”) against three manufacturers of prescription polyethylene glycol 3350 (“PEG”), a laxative drug product. In its lawsuit, Schering …
In August 2007, Teva Pharmaceuticals USA submitted a citizen petition to FDA requesting that the Agency relist in the Orange Book U.S. Patent #5,158,952 (“the ‘952 patent”) covering Janssen Phaemaceutica’s RISPERDAL (risperidone) Tablets (approved under NDA #20-272), and to confirm the company’s eligibility for 180-day …
Earlier this year, we reported on Senator Sherrod Brown’s (D-OH) request to the Congressional Research Service (“CRS”) for information concerning FDA’s “Fast Track” designation program “to help determine whether a case exists for changing or eliminating the 10-year-old initiative that was intended to speed the …
Earlier today, the U.S. Supreme Court announced a 4-4 split in Warner-Lambert v. Kent – just a few days after hearing oral arguments on February 25, 2008. The case, which concerns the narrow issue of a Michigan law immunizing drug companies from products liability claims …
Preemption of state law concerning FDA-regulated products (drugs, devices, and foods) has been the hot topic over the past few weeks. First, on February 20, 2008, the U.S. Supreme Court ruled in Riegel v. Medtronic that preemption principles and the 1976 Medical Device Amendments bar …
In December 2007, we reported on what was a then yet-to-be-released FDA draft guidance on Good Reprint Practices (“GRPs”) and Rep. Henry Waxman’s (D-CA) November 30, 2007 letter to FDA strongly urging the Agency to refrain from disseminating the draft guidance and requesting certain information …
The debate over biogenerics legislation has intensified with the anticipated introduction of legislation to create a “generic biologics” approval pathway and that would grant innovators (i.e., reference product sponsors) and certain generic sponsors market exclusivity. The draft legislation obtained by FDA Law Blog is titled …
Our fellow bloggers over at The Volokh Conspiracy recently posted an interesting story concerning a congressional investigation into Merck/Schering-Plough’s cholesterol absorption inhibitor VYTORIN (ezetimibe; simvastatin). We previously reported on, among other things, a group of letters sent by the U.S. House of Representatives Energy and …
On February 4, 2008, FDA announced that the Bush Administration is requesting nearly $2.4 billion ($1.77 billion in budget authority and $628 million in user fees) for the Agency as part of the Fiscal Year 2009 budget. Of particular interest in the proposed FY2009 budget …
Over the past few weeks, Congress has taken an acute interest in a broad range of FDA issues and FDA-regulated products, penning several letters and holding or expressing intent to hold hearings and investigations on various matters. Below is a list of recent congressional activity: On …
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 …
