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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.
Yachts, Jets, Horses & Hooch: Specialized Commercial Leasing Models
Defining commercial real estate asset class is essentially a property explaining how it identifies — not necessarily what its original intention was or what others think it ought to be. This article discusses, from a general issue-spot and contextual analysis perspective, how lawyers ought to think about specialized leasing formats and the regulatory backdrops that may inform what the documentation needs to contain for compliance purposes.
Hyperlinked Documents: The Latest e-Discovery Challenge
As courts and discovery experts debate whether hyperlinked content should be treated the same as traditional attachments, legal practitioners are grappling with the technical and legal complexities of collecting, analyzing and reviewing these documents in real-world cases.
Identifying Your Practice's Differentiator
How to Convey Your Merits In a Way That Earns Trust, Clients and Distinctions Just as no two individuals have the exact same face, no two lawyers practice in their respective fields or serve clients in the exact same way. Think of this as a "Unique Value Proposition." Internal consideration about what you uniquely bring to your clients, colleagues, firm and industry can provide untold benefits for your law practice.
Risks and Ad Fraud Protection In Digital Advertising
The ever-evolving digital marketing landscape, coupled with the industry-wide adoption of programmatic advertising, poses a significant threat to the effectiveness and integrity of digital advertising campaigns. This article explores various risks to digital advertising from pixel stuffing and ad stacking to domain spoofing and bots. It will also explore what should be done to ensure ad fraud protection and improve effectiveness.
Turning Business Development Plans Into Reality
This article offers practical insights and best practices to navigate the path from roadmap to rainmaking, ensuring your business development efforts are not just sporadic bursts of activity, but an integrated part of your daily success.