Allergy Drugs Forced OTC Switch Not Unconstitutional "Taking" - WellPoint
This article was originally published in The Tan Sheet
An FDA-mandated OTC switch of second-generation antihistamines would not result in an unconstitutional "deprivation of property" for drug marketers, WellPoint Health Networks says in comments to FDA.
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FDA does not have an established procedure in place to prevent the disclosure of protected trade secrets in the event of a forced Rx-to-OTC switch, Center for Drug Evaluation & Research Director Janet Woodcock, MD, told a House panel June 13.
A House subcommittee will examine FDA's legal authority to initiate an Rx-to-OTC switch without the sponsor's consent during a June 13 hearing.
A negotiated compromise between FDA and the manufacturers of second-generation antihistamines seems the most logical way to resolve the legal, regulatory and financial obstacles facing both sides.