Category — FDA Regulations

This post comes courtesy of Troutman Sanders attorneys Diane Romza-Kutz, Robert E. Browne, Jr., and Matthew M. Morrissey, who are members of the Firm’s Life Sciences Team.  We hope you find it useful.

Jan. 4, 2012 — On January 4, 2011, President Barack Obama signed the FDA Food Safety Modernization Act (FSMA) into law. The FSMA purports to address perceived problems with the American food safety regime by empowering the United States Food and Drug Administration (FDA) with new regulatory and enforcement authority. The law creates expansive power for the FDA to regulate both domestic food producers and companies importing food products into the United States. Today, January 4, 2012, marks the one year anniversary of the FSMA and many significant steps have been taken to implement the legislation.

This Advisory will highlight a few of the most important regulatory actions taken pursuant to the  FSMA to date and the major implications for business involved in food production and supply. [Read more →]

Dec. 1, 2011 – Regular blog contributor Brian Fowler has co-authored an article with Troutman Sanders partner Dabney Carr concerning the implications of the Supreme Court’s recent decision in Pliva v. Mensing.  The article appears in the November issue of the International Association of Defense Counsel Product Liability Committee’s newsletter, which can be found here.  Please check it out.

 [These posts come to us from the Troutman Sanders Tobacco Team.  We thought they might be of interest to our readers.]

Second Warnings Suit Filed Against FDA by Big Tobacco 

September 13, 2011 – In early July, we reported that the four leading tobacco companies were threatening legal action against the Food and Drug Administration (FDA) over the nine new graphic cigarette health warnings that must appear on each cigarette package beginning in September 2012.  This threat became a reality last month, when five tobacco companies – R.J. Reynolds, Lorillard, Commonwealth Brands, Liggett Group, and Santa Fe Natural – filed suit in the United States District Court for the District of Columbia against FDA, claiming that the final regulation specifying the new warnings (the “Rule”) violates the First Amendment as applied to Plaintiffs and was promulgated in violation of the Administrative Procedure Act (“APA”).  [Read more →]

[This post comes to us from Diane Romza-Kutz , Robert E. Browne, Jr., John F. Costello, Jr. and Matthew M. Morrissey of Troutman Sanders' Life Sciences Practice Team.  We thought it might be of interest to our readers.]

Sept. 12, 2011 -  The recent furor in the medical device industry over a new recommendation that the U.S. Food & Drug administration abandon its approval process for medical devices has prompted a new round of public meetings and comment. This provides a critical opportunity for the medical device industry to comment on these potential new hurdles to market entry. [Read more →]

[This post comes to us from Diane Romza-Kutz and Seth Erickson of Troutman Sanders' Life Sciences Practice Team.  We thought it might be of interest to our readers.]

July 16, 2011 -  On June 14, 2011, the U.S. Food and Drug Administration (the “FDA”) issued new regulations for sunscreens currently sold over-the-counter (“OTC”) (i.e., without a prescription). The new regulations, which become effective June 18, 2012, establish labeling and testing requirements for OTC sunscreen products containing specific ingredients, or combinations of ingredients, and marketed without an approved application under section 505 of the Federal Food, Drug, and Cosmetic Act (the “Act”). [Read more →]

June 24, 2011 -    I love a good British comedy, and few are better than Monty Python And The Holy Grail.  One of my favorite scenes is “Bring Out Your Dead,” in which John Cleese’s character attempts to put a nearly deceased, elderly man on the “death cart”, while the elderly man cries out “I’m not dead yet….I’m getting better.”  Unfortunately for the old man, as he breaks into cries of “I feel happy…I feel happy,” the scene ends with the mortician, played by Eric Idle, clubbing him over the head to expedite his passing.

Why is this morbid scene on my mind this morning?  Naturally it is because of yesterday’s U.S. Supreme Court decision in Pliva v. Mensing, 131 S. Ct. 2567 (2011), which proves that preemption of prescription drug failure to warn claims based on “impossibility” is indeed not dead yet, even in the wake of the Supreme Court’s 2009 decision in Wyeth v. Levine, 555 U.S. 555, 129 S. Ct. 1187 (2009). [Read more →]