The webinar, led by Captain Valerie Jensen, R.Ph., Associate Director for the FDA’s Drug Shortage Program, discusses how the FDA responds to drug shortages and what they are doing to try to prevent shortages of medically necessary drugs.
According to Capt. Jensen, key to preventing drug shortages is manufacturers letting FDA know early when a shortage is expected. So far in 2011, 99 shortages have been prevented by early notification.
What the FDA Can Do
With voluntary early notification, the FDA can work with manufacturers to:
- Use FDA regulatory flexibility to allow shipping of drugs that have problems that don’t affect patient safety such as misprinted labels or packaging errors.
- Allow shipping of drugs with special warnings or filters. For instance, a drug may be safely used with a filter for particulates or crystals can be dissolved if the medication is heated.
- Speed up approvals of alternate manufacturing sites or encourage other manufacturers to ramp up production.
- Approve importation of drugs if the foreign manufacturing site meets FDA requirements for Good Manufacturing Practices.
- Approve new sources of acceptable raw materials — as they did after the Japan earthquake.
What the FDA Can NOT Do
- FDA has no authority to require manufacturers to make any drug.
- FDA can’t tell manufacturers what quantity of a drug to make or release.
- FDA can’t set prices or interfere in pricing.
Currently, only manufacturers who are the single source of a medically necessary drug are required by law to inform FDA of their intention to stop making it. There is no penalty for not doing so.
While Capt. Jensen cannot comment on proposed legislation, she emphasized the importance of early notification of potential shortages.
A specific question from a listener to Capt. Jensen about 5-FU led to a hopeful answer. She replied that two companies are continuing to produce 5-FU and that the shortage probably is resolving based on what those companies are telling FDA.
For lists of drugs that are currently in shortage and information about when those shortages may be resolved:
To take an critically necesssary first step toward preventing future shortages, ask your Members of Congress to support the Preserving Access to Lifesaving Medications Act (H.R. 2245/Sen 296).