This Week – April 27, 2012
This Week in Washington DC:
- ACG Working with Congress to Revise Drug Shortages Legislation
Senate HELP Committee Passes Legislation on Drug Shortages
On Wednesday, April 25th, the Senate Committee on Health, Education, Labor, and Pensions (HELP) agreed to legislation that reauthorizes the Food and Drug Administration (FDA) drug/device manufacturer user fee program as well as expands the categories of drugs and circumstances when manufacturers must notify the FDA before ceasing production in an effort to prevent future drug shortages. This legislation now heads to the Senate floor or will be merged into a larger legislative vehicle for the full Senate to consider as soon as next month. Current law requires only sole source drug manufacturers to notify the FDA within six months of discontinuing products that are considered “life-supporting, life-sustaining, or used in the prevention of a debilitating disease or condition.” While various bills on Capitol Hill would require all drug manufacturers to notify the FDA before ceasing production, notification still applies to only these “life-supporting, life-sustaining, or prevention of a debilitating disease” categories. ACG applauds Congress for recognizing the gravity of the problem but fears that the shortages of sedatives, narcotics, and other drugs currently impacting many ACG members could be interpreted to be outside the scope of the legislation.
The Senate HELP Committee’s bill expands these categories of drugs that require FDA notification. However, ACG is urging lawmakers to further revise this language to ensure it applies to all drugs in clinical GI, such as “in the screening, prevention, or treatment of a debilitating disease or condition.” While FDA notification alone may not prevent all drug shortages from occurring, it will allow the agency time to prepare for a shortage as well as the opportunity for other manufacturers to help mitigate any potential shortage. ACG is currently working with the relevant Senate and House committees and other members of Congress to incorporate these recommended revisions. ACG will continue to be a strong advocate on Capitol Hill on behalf of the GI clinician.
Please stay tuned for further updates. Please also share and discuss your thoughts with fellow ACG members on the ACG GI Circle. To login and share your comments, go to www.gi.org and sign in as a member. Once you have done so, click here and then click the orange "Visit ACG GI Circle" button to be taken to the GI Circle site. If you have not yet activated your ACG GI Circle account, please email us at email@example.com.
Contact Brad Conway, VP Public Policy, with any questions or for more information.