Last week, we reported on several citizen petitions submitted to FDA by Mylan and Pfizer concerning the availability and applicability of 180-day exclusivity and pediatric exclusivity to amlodipine drug products. FDA has also established a separate docket to solicit the views of interested parties on …
During the past several years, government enforcement authorities have focused an increasing amount of attention on the marketing activities of medical device companies. This increased scrutiny has taken the form of investigations through subpoenas and intervention in qui tam lawsuits (lawsuits initiated by a third …
“Orphan drugs” are products recognized by FDA that are intended for use in a “rare disease or condition” ─generally a disease or condition with a United States prevalence less than 200,000 persons. Because the market for orphan drugs is often limited, Congress and FDA have …
On March 16, 2007, the U.S. District Court for the District of Utah ruled that FDA’s 2004 rulemaking banning ephedrine alkaloid dietary supplements [EDS] was “procedurally and substantively proper.” Nutraceutical and Solaray brought the suit against FDA to prevent the Agency from enforcing its 2004 …
A recent California case, In re CV Therapeutics, Inc. Securities Litigation, raised the question of whether, within the context of the attorney-client privilege, regulatory advice provided by food and drug attorneys qualifies as “legal” (protected) advice or “business” (generally not protected) advice. The court concluded …
Yesterday, FDA’s Cellular, Tissue and Gene Therapies Advisory Committee voted in favor of Dendreon Corp.’s PROVENGE (sipuleucel-T), an autologous active cellular immunotherapy intended to treat men with asymptomatic metastatic androgen independent prostate cancer. The committee unanimously voted (17-0) that PROVENGE is reasonably safe for the intended …
In FDA’s “Guide to Minimize Microbial Food Safety Hazards of Fresh-Cut Fruits and Vegetables,” FDA states that Americans are eating more fresh produce, to the point that fresh-cut products are the produce industry’s “fastest growing segment.” Fresh-cut food processors are now faced with the task …
The Federal Circuit’s March 22, 2007 decision invalidating Pfizer’s patent on NORVASC (amlodipine besylate), and Mylan’s commercial launch of its generic version approved under ANDA #76-418 later that day triggering the company’s 180-day exclusivity period has set off a flurry of activity, both in the …
The Deficit Reduction Act of 2005 (“DRA”) provided that any entity that receives or makes annual payments under a Medicaid State plan of at least $5,000,000 must, as a condition of receiving such payments, establish written policies for employees, contractors, and agents that provide detailed …
On March 22, 2007, the Senate Appropriations Committee approved S. 965, a bill making emergency appropriations primarily for the wars in Iraq and Afghanistan. During the Committee’s consideration of the bill, it adopted an amendment offered by Senator Dick Durbin (D-IL) regarding the Medicaid Program. …
As the backlog of pre-Medicare Modernization Act (“MMA”) ANDAs is cleared and disputes over 180-day exclusivity under the old statutory regime become a vestige of the past, new post-MMA disputes over 180-day exclusivity will certainly take their place, particularly as they concern forfeiture. Indeed, within …
Although we launched this blog only two weeks ago, word is spreading fast that FDA Law Blog is a valuable source of information on timely and often overlooked issues affecting FDA-regulated industries. Today, FDA Week, an industry publication from Inside Washington Publishers, ran an article …
The Washington Legal Foundation (WLF), a public-interest law and policy center, has challenged FDA’s authority to regulate laboratory developed tests (LDTs), as well as FDA’s proposed method of changing its regulations governing analyte specific reagents (ASRs), which are components of LDTs. LDTs are commonly referred …
Earlier today, FDA announced the availability of a draft guidance document “that would implement a more stringent approach for considering potential conflicts of interest for its advisory committee members and for recommending eligibility for meeting participation.” The new guidance document, once finalized, will replace a …
On March 12, 2007, Greenberg Traurig submitted a citizen petition to FDA to switch four prescription antihistamine and antihistamine-decongestant drugs from prescription to OTC status. The four drugs are ALLEGRA (fexofenidine HCl), ALLEGRA D (fexofenidine HCl; pseudoephedrine HCl), ZYRTEC (cetirizine HCl), and ZYRTEC D (cetirizine …
