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AHA: Senate plan on drug shortages is a step forward

April 16, 2012
The AHA last week called a bipartisan Senate proposal for addressing prescription drug shortages as part of user fee legislation “a significant first step toward ensuring that patients have access to the medications they need.”

Developed by a bipartisan working group of 18 senators, the 14-page draft proposal would require most makers of life-saving drugs to notify the Food and Drug Administration (FDA) at least six months before discontinuances and interruptions that could lead to disruptions in U.S. supplies.

But the draft would provide several possible exceptions for companies to miss the time frame, such as economic hardship, supply issues or public health concerns.

The proposal would direct the FDA to expedite inspections and reviews of manufacturing sites or new products that could be helpful in addressing a drug shortage, and require the FDA to keep detailed records of previous drug shortages and the actions taken to prevent them.

It also would establish a task force to create a strategic plan to improve communication within the FDA and with public stakeholders, as well as report to Congress on price gouging and how pricing structures factor into drug shortages. The committee plans to mark up legislation by the end of this month.

In comments on the proposal, submitted to the Senate Health, Education, Labor and Pensions Committee, the AHA noted that “the number of drugs in critically short supply is increasing at an alarming rate and threatens quality of care in hospitals nationwide.”

The AHA said many of these drugs play a critical role in lifesaving treatments. “The potential harm to patient safety is of paramount concern,” the association added.

The AHA expressed support for many of the draft proposal’s key provisions, but said it could be “further improved to ensure that the true goal of eliminating generic drug shortages is accomplished.”

The AHA recommended Congress:

Institute civil monetary penalties or another enforcement mechanism to ensure compliance with the requirement for drug manufacturers to report production interruptions or product discontinuations; Include clinicians, patients and supply chain members in the task force created by the legislation to promote inter- and intraagency coordination, planning and decision making; Require the FDA to provide public notification about drug shortages, including adding the reason for the shortage and the anticipated duration, when possible; Require the FDA and Drug Enforcement Administration to collaborate, with appropriate flexibility where needed, to develop quotas for manufacturers producing controlled drugs;


Allocate more resources to the FDA to address drug shortages.

The AHA also expressed support for the proposal’s early notification requirement. But the association asked the working group to reconsider the exception for economic hardship, saying it does not believe “economic hardship suffered by a manufacturer outweighs the hardship of an untimely death due to a medication in short supply.” The AHA also supports the proposal’s inclusion of both biologics and biosimilar products.

The AHA’s recommendations are similar to those offered in an April 6 letter to the working group by the American Society of Health-System Pharmacists, the Children’s Hospital Association, eight hospitals and 12 other health care organizations.

“This problem has become a national crisis and we must take steps to address it now,” wrote the groups, which included the Cleveland Clinic, MUSC Children’s Hospital in Charleston, SC, NYU Langone Medical Center in New York City, Johns Hopkins Medicine in Baltimore, University of Utah Health Care in Salt Lake City, Stanford Hospital & Clinics in Palo Alto, CA, Trinity Health in Novi, MI, and University of Michigan Hospitals and Health Centers in Ann Arbor.

The FDA said the number of drugs in short supply, which include cancer, anesthesiology and nutrition medications, rose to 220 in 2011 from 56 in 2006, the year a clear trend started emerging.

Many of the drugs are generic, sterile injectable medications, such as cytarabine, a key treat- ment for leukemia, or fluorouracil, for colon and other cancers.

For more on the AHA’s letter, go to “Advocacy Issues” at www.aha.org and click on “Letters” under “Tools & Resources.”

For more on the Senate committee’s proposal, visit www.help.senate.gov.

Every five years, Congress has to reauthorize the FDA’s authority to help fund its approval process for life-saving drugs and medical devices by collecting user fees from the companies it regulates.

Congress is slated to do that before the authority expires Sept. 30.

User fees for drugs were first authorized in 1992 under the “Prescription Drug User Fee Act,” and similar fees for medical devices were created in 2002 under the “Medical Device User Fee Act.”

This year, Congress also is expected, for the first time, to authorize user fees on the generic pharmaceutical industry, the “Generic Drug User Fee Act,” and on generic biologics, such as vaccines or serums created from animal products or other biological sources – the “Biosimilar User Fee Act.”

Under agreements between the FDA and industry groups, prescription drug makers will pay $693 million over five years in user fees, about 60% of the FDA budget to regulate drugs. Makers of pacemakers, stents, defibrillators and other medical devices will pay $595 million over five years in user fees, 35% of what it costs the FDA to regulate the device industry.