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FDA Cannot Force an Over-the-Counter Drug Switch
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.
The agency has under active consideration a 1998 Citizens Petition filed by WellPoint Health Networks, a health insurer, requesting that the FDA force the manufacturers of three leading allergy medications — Allegra/Allegra-D, Claritin/Claritin-D, and Zyrtec — to switch these products from Rx to OTC status. In a 2002 petition, WellPoint added a fourth drug, Clarinex. Claritin's manufacturer has voluntarily switched that product, but the makers of Allegra, Zyrtec, and Clarinex are contesting the FDA's authority and the wisdom of forcing a switch. High-ranking FDA officials have been quoted in the press stating that FDA has such authority.
But there is much authority to suggest the FDA lacks authority to force an unwilling manufacturer to switch its distribution channels from prescription to OTC. When one examines the applicable section of the Food, Drug and Cosmetic Act (FDCA or the Act), the authority just is not there. The FDA may, through a rulemaking, remove the requirement that a company limit its product to prescription use only. However, nothing in the Act authorizes the FDA to take the next step and prohibit Rx or require OTC distribution of a safe drug.
Major Differences In UK, U.S. Copyright Laws
This article highlights how copyright law in the United Kingdom differs from U.S. copyright law, and points out differences that may be crucial to entertainment and media businesses familiar with U.S law that are interested in operating in the United Kingdom or under UK law. The article also briefly addresses contrasts in UK and U.S. trademark law.
Strategy vs. Tactics: Two Sides of a Difficult Coin
With each successive large-scale cyber attack, it is slowly becoming clear that ransomware attacks are targeting the critical infrastructure of the most powerful country on the planet. Understanding the strategy, and tactics of our opponents, as well as the strategy and the tactics we implement as a response are vital to victory.
The Article 8 Opt In
The Article 8 opt-in election adds an additional layer of complexity to the already labyrinthine rules governing perfection of security interests under the UCC. A lender that is unaware of the nuances created by the opt in (may find its security interest vulnerable to being primed by another party that has taken steps to perfect in a superior manner under the circumstances.
Removing Restrictive Covenants In New York
In Rockwell v. Despart, the New York Supreme Court, Third Department, recently revisited a recurring question: When may a landowner seek judicial removal of a covenant restricting use of her land?