When it comes to Congressional action on drug shortages, “newer” is not always “better.” An earlier PDUFA discussion draft (House side) would have mandated the FDA to:
… include a list of the drugs that are subject to the requirements of section 506C(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356c(a)), as amended by subsection (a), if the manufacture of such drug is to be discontinued, or an interruption of the manufacture of the drug that is likely to produce a drug shortage;”
Nice. Clear. Matching authority and expertise.
The current version reads:
IN GENERAL. -- A manufacturer of a drug subject to section 503(b)(1) -- (1) that is -- (A) life-supporting; ‘(B) life-sustaining; or (C) intended for use in the prevention or treatment of a debilitating disease or condition; and (2) that is not a radio pharmaceutical drug product, a product derived from human plasma protein and their recombinant analogs, or any other product as designated by the Secretary, shall notify the Secretary of a discontinuance of the manufacture of the drug, or an interruption of the manufacture of the drug that is likely to lead to a meaningful disruption in the manufacturer’s supply of the drug, and the reason for such discontinuance or interruption, in accordance with subsection (b).
Very vague as to what drugs fall into these categories and what, precisely, those circumstances might be.
The Senate-side language is equally unclear:
IN GENERAL.-- A manufacturer of a drug -- (1) that is -- (A) life-supporting; (B) life-sustaining; (C) intended for use in the prevention of a debilitating disease or condition; (D) a sterile injectable product; or (E) used in emergency medical care or during surgery; and (2) that is not a radio pharmaceutical drug product, a human tissue replaced by a recombinant product, a product derived from human plasma protein, or any other product as designated by the Secretary, shall notify the Secretary, in accordance with subsection (b), of a permanent discontinuance in the manufacture of the drug or an interruption of the manufacture of the drug that could lead to a meaningful disruption in the supply of that drug in the United States.
Considering the high profile nature of this issue and the need for manufacturers to err on the side of both patient safety and legal prudence, lack of clarity will very likely lead to reporting everything, thus exacerbating a signals-to-noise problem at an already over-burdened FDA.
Perhaps the best solution is for Congress to require the FDA to compile and publish a list of drugs that must be reported to the agency when circumstances leading to potential shortages arise. This would allow companies to determine when they need to contact the FDA – and allow them to do so more swiftly and efficiently. Such legislative authority would also focus the FDA’s energy on the most critical drug shortage situations – allowing them (with their limited staffing resources – it’s worth repeating) to address them with greater skill and alacrity.
Noise proves nothing. Often a hen who has merely laid an egg cackles as if she laid an asteroid.
-- Mark Twain
