Does the Food and Drug Administration have authority to force manufacturers of prescription drug products to switch those products to over-the-counter (OTC) distribution against their will? The FDA is currently grappling with this issue, a dispute that has generated substantial controversy, including statements by FDA officials and coverage in leading newspapers.
Chief Justice Ralph J. Cappy of Pennsylvania's Supreme Court issued an opinion on Dec. 31, 2003, declaring that the State of Pennsylvania would remain a "Frye state" and would not follow suit with much of the rest of the nation in using the Daubert test to qualify expert witnesses.
The latest information from the Agency.
Illinois governor Rod R. Blagojevich sent a letter on December 22 to Secretary of Health and Human Services Tommy Thompson asking that Thompson approve Illinois' plan to import pharmaceutical products from Canada for use by the state's employees and retirees. The governor, who has been pushing for months to gain the right to purchase drugs for Illinois from less-expensive sources in Canada, stated in his letter, "I was encouraged by your recent statements regarding your willingness to approve a small-scale demonstration project around the issue of re-importation of prescription drugs from Canada. We would like to work with you to design an effective pilot program that complies with the law." Blagojevich hopes his state will become the "small-scale demonstration project" Thompson spoke of.
The latest news of importance to you and your practice.
Fen-Phen litigation is entering a critical phase that promises to be at least as complex and contentious as anything that preceded it. The national settlement that was supposed to buy peace is now smack in the middle of the storm that swirls, as always, around Wyeth. Claims against the Madison, NJ-based drug manufacturer are moving slowly through the $3.75 billion trust Wyeth funded to compensate people whose heart valves were damaged by its diet drugs. Lawyers and clients have been highly critical of the delays.
Recent rulings of importance to you and your practice.
In order to avoid drowning in the sea of mass tort litigation, drug and medical device companies must aggressively and "offensively" defend these actions -- and do so as soon as the mass tort litigation emerges. Critical to stemming the mass tort tide is an understanding of the factors that drive the filing of these actions against pharmaceutical and medical device companies: 1) the ease with which controversial issues relating to drugs and medical devices can be recognized; and 2) complicated causation issues. Armed with that understanding, the single most important pre-trial goal for any defendant must be the early exposure of frivolous claims based on tenuous causation and junk science.
A study whose results were reported December 8 asserts that the pharmaceutical industry's "blockbuster" approach to developing new drugs is no longer viable in today's marketplace.
The Canadian National Association of Pharmacy Regulatory Authorities (NAPRA), Canada's voluntary umbrella association of provincial and territorial pharmacy licensing bodies, has asked the Canadian government to legislate against the export of drug products to the United States.
