ASCO continues to call for three specific actions by Congress to help avert shortages of essential treatments for children and adults living with cancer. ASCO President Michael P. Link, MD, outlined the priorities in February at an FDA news briefing on the recent methotrexate and liposomal doxorubicin (Doxil) shortages.
In his remarks, Dr. Link called for Congress to appoint a joint U.S. House and Senate bipartisan working group to develop permanent legislative solutions within 60 days. He then outlined three priorities that ASCO believes are essential to address shortages:
- Require advance notification of potential shortages—FDA should receive confidential notification from manufacturers of market withdrawals or manufacturing interruptions 6 months in advance, or as soon as such problems become known. This information is essential to FDA’s ability to help address manufacturing issues or to identify alternative drug sources before shortages occur.
- Provide economic incentives to ensure continued availability—Congress should provide incentives for companies to develop contingency plans, for example, involving alternate suppliers of raw materials and redundancies in manufacturing. Additional incentives should be considered to encourage manufacturers to enter and remain in the market for essential medications that are susceptible to shortage.
- Establish FDA user fees for generic drugs—Expand FDA’s authority to collect user fees from generic drug manufacturers as part of the regulatory approval process, similar to fees paid by branded drug makers. These fees should be used to ensure that FDA has the resources to quickly review applications for generic drugs either in or at risk of shortage, and speed the availability of these medicines to patients. The fees would also provide flexibility for FDA to incentivize production of key drugs, for example, by charging reduced fees for companies that demonstrate adequate contingency plans for manufacturing disruptions.
ASCO will continue to call on Congress to pass legislation with these solutions. Please continue to visit ASCO in Action (ascoaction.asco.org) for the latest information on the Society’s efforts in resolving the oncology drug shortage crisis. ■
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