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 Anne Marie Murphy – As we have reported previously, Title VIII of the Food and Drug Administration Amendments Act of 2007 (“FDAAA”) amended the Public Health Service Act (“PHS Act”) by adding new section 402(j), 42 U.S.C. § 282(j), which greatly expands the types …
By Alan M. Kirschenbaum – Today’s Federal Register announces FDA’s issuance of a final “Guidance for Industry on Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical …
By Jeffrey N. Wasserstein, Michelle L. Butler, and Jamie K. Wolszon – On December 18, 2008, the Advanced Medical Technology Association (“AdvaMed”) announced the release of a newly revised version of the “Code on Ethics on Interactions with Healthcare Professionals,” which is a voluntary code focusing …
By Kurt R. Karst – Earlier today, by a five-to-four vote, the U.S. Supreme Court ruled against preemption in Altria Group, Inc. Good, the so-called “light cigarette” case. Background on the case is available via the SCOTUS Wiki. The respondents in the case (i.e., Good …
By Bryon F. Powell – On November 26, 2008, the Massachusetts Department of Public Health delayed plans to propose emergency regulations that would implement the state’s recently enacted pharmaceutical and device marketing law at a December 10 meeting of the Public Health Council. A pair …
By James R. Phelps & Kurt R. Karst – On November 17, 2008, Representatives John Dingell (D-MI), Chairman of the Committee on Energy and Commerce, and Bart Stupak (D-MI), Chairman of the Subcommittee on Oversight and Investigations of the U.S. House of Representatives, announced their most …
FDA’s Office of Combination Products (“OCP”) recently released a draft guidance entitled “New Contrast Imaging Indication Considerations for Devices and Approved Drug and Biological Products.” The draft guidance permits diagnostic imaging device makers to expand labeling for use with a contrast agent or radiopharmaceutical even …
Representative John Dingell (D-MI) has revised several of the drug-related sections of the Discussion Draft of the FDA Globalization Act (“FDAGA”). We first reported on the Discussion Draft, which has received significant attention from industry and stakeholder groups alike, in April 2008. Updated sections of the …
On August 1, 2008, FDA will publish a Federal Register notice announcing the Fiscal Year (“FY”) 2009 user fee rates established under the Prescription Drug User Fee Act (“PDUFA”). A similar notice will also be issued with the FY 2009 user fee rates established under …
On June 26, 2008, ranking Republican of the U.S. House of Representatives Energy and Commerce Committee, Representative Joe Barton (R-TX), along with several co-sponsors, introduced the “Strengthening of FDA Integrity Act of 2008” (H.R. 6378). According to an Energy and Commerce Committee Republicans press release, …
Are state law personal injury suits against drug and device manufacturers preempted by federal regulation of these products? This question has been the subject of much litigation since the early 1990s. The U.S. Supreme Court has issued a string of decisions in this area, with one …
The latest issue of the Food and Drug Law Institute’s “Update” magazine features articles written by three Hyman, Phelps & McNamara, P.C. attorneys. The first article, titled “FDA Moves Against Marketed Unapproved Human Drugs,” was written by Susan J. Matthees and John R. Fleder and …
On May 1, 2008, a federal judge in the Middle District of Florida brought some measure of closure to FDA’s more than six years of attempts to regulate a self-identified custom device manufacturer. In his May 1st order, Judge G. Kendall Sharp mostly sided with …
Earlier this year, we reported on a provision in Title VIII of the FDA Amendments Act (“FDAAA”) requiring 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”) § …
