Today, President Obama signed the Food and Drug Administration Safety and Innovation Act into law. The bill passed both houses of Congress late last month with broad, bipartisan support. The Lance Armstrong Foundation endorsed and advocated for passage of this legislation, which includes a number of key provisions to help alleviate critical cancer drug shortages. The new law does the following:
- Reauthorizes the law permitting the FDA to collect user fees from makers of prescription drugs and medical devices, and allows the agency to begin collecting user fees for generic drugs. The new generic drug user fee will provide $1.5 billion over five years in additional resources for the review and regulation of generic drugs. The industry agreed to this fee in return for faster and more predictable review of generic drug applications and increased inspections of drug facilities.
- Modifies existing reporting requirements for manufacturers of drugs that are life-supporting, life-sustaining, and intended for use in the prevention or treatment of a debilitating disease or condition, including those used in emergency medical care or surgery. Manufacturers will now be required to give the FDA 6 months notice if they plan to discontinue or interrupt the production of a drug that could lead to a supply disruption.
- Authorizes the FDA to expedite inspections and applications that could help mitigate or prevent shortages.
- Requires the FDA to establish a task force to enhance the response to shortages, and create a strategic plan to address shortages.
- Requires the FDA to maintain a drug shortage list and provide patients, providers and the public with such information in order to prevent, mitigate, and manage drug shortages on the ground.
- Allows hospitals within the same health system to repackage drugs into smaller units to alleviate drug shortages.
- Calls for a GAO study to examine the causes of drug shortages and issue recommendations on how to prevent or alleviate them. This provision would provide needed data on how the regulatory framework, manufacturing challenges, or other factors contribute to drug shortages, as well as recommendations to address such issues.
While this new law does not address the economic and pricing aspects of drug shortages, passing this legislation was an important step towards addressing a very complex problem. The Lance Armstrong Foundation will continue to monitor the cancer drug shortage problem as the FDA moves to implement these new provisions.