New House Drug Shortage Bill Focuses on FDA Reforms
Published on: February 16, 2012
Bipartisan House legislation introduced on January 31 would expedite Food and Drug Administration (FDA) review of drugs in shortage, improve communication within the agency and with stakeholders about possible shortages, and increase Drug Enforcement Administration (DEA) quotas for medications in short supply. The newly introduced legislation is intended to be part of the conversation around possible broader solutions to the drug shortage problem that could include bills that have already been introduced in the House and Senate (S. 296/H.R.2245, the Preserving Access to Life-Saving Medications Act) mandating early notification by manufacturers of drugs in short supply.
The Drug Shortage Prevention Act (H.R. 3839), co-sponsored by Representatives John Carney (D-DE) and Larry Bucshon (R-IN), seeks to address a number of possible short-term fixes to the drug shortages that can be implemented fairly quickly and seeks to build on authority FDA already has, including:
- Requiring the FDA to identify drugs that are vulnerable to shortages and mandate expedited review and approval of these medications, with standards to be defined by the agency. The FDA would also be required to expedite review of changes to manufacturing processes or facilities of drugs in shortage, and expedite approval of an application for an alternative active pharmaceutical ingredient (API) supplier of these medications.
- Requiring the FDA to notify distributors of an imminent critical drug shortage, a move intended to cut down on the so-called gray market, while also allowing the agency to withhold notification to a distributor determined by the Attorney General to be stockpiling, price gouging or engaging in other unlawful activities related to distribution of a drug in shortage. In addition, the FDA would have to develop a system to notify members of the public -- including providers and patients -- when a drug is added to the drug shortage list.
- Mandating closer internal communications between FDA's regulatory staff and its drug shortage team, including requiring FDA to communicate any new regulatory concern identified about a critical drug -- including possible manufacturing problems -- within one business day to the FDA drug shortage office and within five business days to the manufacturer.
- Allowing the Attorney General to determine whether it is appropriate to increase one or more DEA quotas to address a drug shortage, and mandate that DEA, in consultation with FDA, increase the quota for controlled substances on the shortage list to address a shortage.
- Requiring the Secretary of Health and Human Services to conduct a feasibility study to determine the efficacy and logistics associated with creating a national contingency plan in the event of a critical drug shortage, including the creation of a national stockpile for these drugs.
Many of the proposals in the bill have been discussed as potential solutions to the drug shortage problem as the issue has garnered increased attention on Capitol Hill. However, the bill does not address possible changes to reimbursement or other financial incentives that have been proposed as solutions to the drug shortage problem.
Representative Joe Pitts (R-PA), chairman of the House Energy and Commerce Health Subcommittee, recently indicated that House leadership is looking for areas of bipartisan agreement on drug shortages, including ways to expedite and encourage production of these drugs along with early notification and greater transparency, and that there is still debate over the role reimbursement is playing in the shortage problem. Sources have indicated that the House Energy and Commerce Committee is leaning more towards early notification and regulatory reforms over reimbursement changes as possible solutions, which lawmakers see as having a greater likelihood of moving forward. However, Senator Orrin Hatch (R-UT), who has been championing the reimbursement idea, is still trying to garner support in the Senate and may offer an amendment to the user fee legislation that would address the reimbursement issue, rather than introducing a stand-alone bill.
The bill received positive feedback from staff on the House Energy and Commerce Committee, which is looking at drug shortage legislation ahead of reauthorization of the Prescription Drug User Fee Act (PDUFA). The user fee bill is likely to be the vehicle to move any drug shortage proposal, with the Committee expected to debate potential solutions to the drug shortage problem during user fee hearings scheduled throughout February.
Over the past year, shortages of drugs used to treat patients with hematologic malignancies, including leukemia and lymphoma, have become critical and life-threatening. ASH has taken several steps to resolve these drug shortages, including alerting and working with the FDA and Congress. ASH recently sent a letter to Representatives Carney and Bucshon in support of their efforts and will continue to work with them and other congressional champions to build support for legislation to help prevent and mitigate drug shortages.
ASH advocacy efforts are having impact. ASH was the first medical society to call on Congress to conduct hearings and has made recommendations on ways to prevent and mitigate drug shortages that are being incorporated into legislative and regulatory efforts. For more details, please visit the Drug Shortages Update Page on the ASH website.
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