Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at email@example.com if you need assistance.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
RAPS recognizes that the current situation in Ukraine impacts our members and customers on many levels. If you are directly impacted by the current situation in the region and are challenged to meet your deadlines or obligations to RAPS, please reach out to firstname.lastname@example.org so that we can defer those challenges. Your health and safety are paramount to us.
Posted 11 May 2012
In early 2011, several bills aiming to curb drug shortages were introduced in the US House of Representatives and the US Senate. Despite the bills' bipartisan nature and widespread support, they've languished in Congressional committees ever since. Now, reports CBS, there are signs that both bills could see passage before the end of the year.
The bills, House and Senate versions of the Preserving Access to Life-Saving Medications Act (H.R. 2245 & S. 296), would require pharmaceutical manufacturers to notify the US Food and Drug Administration (FDA) of any impending drug shortages.
"Both [political] parties and the President support the bills, yet they haven't passed," reports CBS.
The bills are sponsored by, among others, Sens. Susan Collins (R-ME) and Amy Klobuchar (D-MN), and Reps. Diana DeGette (D-CO) and Tom Rooney (R-FL).
For DeGette, the slow progress on the bills has been a source of constant frustration.
"I have never seen a Congress where it is more difficult to pass legislation," remarked DeGette, who implored CBS to contact the congressional leadership to press them on the issue.
Klobuchar, too, has shown her inpatience in the past. In February, Klobuchar threatened to attach the bill to a must-pass highway bill. At that time, the legislation had already attracted 63 co-sponsors in the House and 23 co-sponsors in the Senate-no small feat in a highly polarized Congress.
Both Speaker of the House John Boehner (R-OH) and Senate Majority Leader Harry Reid (D-AZ) said the legislation will come before their respective full chambers "soon," and CBS notes the legislation could receive committee votes by Memorial Day (28 May 2012).
The bill would provide FDA with the authority to require manufacturers to notify them of impending shortages. A 15 December 2011 report by the Government Accountability Office (GAO) noted FDA lacked the statutory authority to make such requirements of the pharmaceutical industry.
While FDA has instituted a voluntary plan-one which the agency has touted as being widely successful-it still says drug shortages "remain a serious, complex problem."
"The industry has to not be afraid to let FDA know if they have a problem, so that we can get in there and work with them to fix it before it results in a shortage," said Margaret Hamburg, Commissioner of FDA.
CBS - Bill that would help curb drug shortages headed for vote after 15-month delay
Regulatory Focus - Hamburg Touts Agency's Efforts to Curb Drug Shortages
Regulatory Focus - GAO Report Finds That FDA Needs Increased Authority to Address Shortages
Regulatory Focus - Senator: Drug Shortage Bill Could Be Bundled With Highway Bill
Tags: Alleviate, PALM Act, House, Shortages, Latest News, Hamburg, Senate, Bill, Congress, pharmaceutical, Reduce, drug
Regulatory Focus newsletters
All the biggest regulatory news and happenings.