Sen. Amy Klobuchar (D-Minn.) introduced the Preserving Access to Life-Saving Medications Act in early 2011. Later that year, Rep. Diana DeGette (D-Colo.) sponsored a House version of the bill.
The legislation would require drug manufacturers to notify the Food and Drug Administration at least six months in advance of a manufacturing discontinuance, planned interruption or adjustment of certain drugs.
The number of drug shortages has been rising since 2006. There were 250 drug shortages in 2011, compared with 178 in 2010, according to the FDA.
“We are concerned that a requirement lacking enforcement is not really a requirement,” the AHA said in the April 10 letter. “Simply listing the names of manufacturers who fail to comply in an annual report to Congress will not serve as an effective enforcement action.”
The AHA is also requesting that an “economic hardship” clause that would exempt sole-source manufacturers from reporting to the FDA be removed except in the case of a bankruptcy filing and that the list of manufacturers that do not comply with the early notification requirement be made public if there are no civil monetary penalties.
On April 6, the American Society of Health-System Pharmacists sent a letter to Harkin and Enzi expressing similar concerns about the current status of the discussion draft of the bill.
The association is also requesting that the working group consider including civil monetary penalties or other types of enforcement to ensure compliance with the early notification requirement.
“One concern we have is whether this reporting is mandatory,” the ASHP said in the letter. “Typical agency enforcement actions available for current use include injunctions or halting production, however, these types of enforcement actions would have no impact on drug shortages, and, in fact, could make them worse.”
Other organizations that have called for civil monetary penalties to be included in the legislation include the American Academy of Emergency Medicine, the American Society of Hematology, the American Academy of Emergency Medicine and the Children's Hospital Association, according to an AHA spokeswoman.