Most of the proposals already made by subject-matter experts pretty much go along with those the president and Congress are entertaining. First and foremost, they want to legislate that drug makers give a six-month warning to the FDA before a shortage occurs.
Experts note that shortages are “occurring in an environment that is characterized by a near absence of communication between drug manufacturers and the FDA,” because the FDA cannot always force manufacturers to give early warnings under its current regulatory powers. Pharmacists and doctors are frustrated that they do not see these shortages coming and do not know how long they will last.
The American Society of Health-System Pharmacists, the American Society of Anesthesiologists, the American Society of Clinical Oncology, and the Institute for Safe Medication Practices have generally agreed that the FDA’s lack of power to compel notification from manufacturers is a significant contributor to shortages. The American Society of Health-System Pharmacists recommends increased FDA power to require notification from manufacturers, especially manufacturers of single-source products. These notifications could be confidential. The confidentiality clause would reduce the risk of hospitals and doctors hoarding the drug in question, but this precaution would not really be a solution to the shortage.
The Generic Pharmaceutical Association proposes that an independent third party, among other things, gather the information on forthcoming delays, a mechanism the trade association calls the “Accelerated Recovery Initiative.” The GPhA also supports another legislative measure that might have an impact on the supply of generic drugs, including injectable drugs: the adoption of user fees, payable to the FDA, to fund new approvals of generic drugs and manufacturing facilities. This system is likely to be legislated in the renewal of the Prescription Drug User Fee Act, which the GPhA endorses with an offer to support a five-year levy against its members of $299 million in user fees.
This would be the first time that the generic pharmaceutical industry has been charged user fees by the FDA (the research-based pharmaceutical industry has paid user fees to the FDA for two decades). GPhA believes that by offering to fund the FDA with its members’ user fees, the approval process for generic drugs — currently severely blocked — will become faster.