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Executive Briefing Series (formerly The Food & Drug Letter)
March 9, 2012 | Full Issue in PDF Format
Drug shortages hit an all-time high in 2011. According to the University of Utah Drug Information Service, 267 drugs — mostly sterile injectables—were in short supply, up from 211 in 2010 and 58 in 2004. While the majority stem from quality manufacturing issues, other reasons include production delays, problems getting active ingredients and discontinuations. With no signs the problem is abating, the White House ordered the FDA to ride roughshod on drugmakers that don’t give adequate advance notice of potential drug discontinuances or shortages. In February, the agency issued an interim final rule requiring drugmakers to report interruptions in the manufacture of critical drugs and guidance on reporting requirements for drug shortages. The agency also announced steps to boost supplies of critically needed cancer drugs, including allowing the temporary importation of a replacement drug for Doxil (doxorubicin hydrochloride liposome injection) and approving a new producer of preservative-free methotrexate. This issue of The Food & Drug Letter brings readers up to date on what the FDA is doing to prevent drug shortages and possible further actions by the agency and Congress.
The FDA has issued an interim final rule requiring drugmakers to report interruptions in the production of critical drugs.
Drugmakers should voluntarily notify the FDA of product quality problems, manufacturing interruptions and delays in acquiring raw materials to help prevent drug shortages, the agency says in draft guidance published in the Feb. 27 Federal Register.
Generic drugmakers need to correct manufacturing quality issues that are the main culprit behind drug shortages or face eroding consumer confidence in their copycat drugs, FDA Commissioner Margaret Hamburg says.
Marketing applications for drugs in short supply could see expedited review under the Drug Shortage Prevention Act introduced in the House in early February.
IMS Health is urging the FDA and drugmakers to create an early warning system to avoid supply problems that lead to drug shortages.
If Congress mandates early alerts about drug shortages, implementation should get close monitoring and there should be audits of the FDA process for collecting data from drugmakers, an expert told senators.
In October, President Barack Obama ordered the FDA to use its legal authority to require drugmakers to provide adequate advance notice of manufacturing changes and mishaps that could lead to a medication shortage.
Drugmakers need incentives from Congress and the FDA to create improved manufacturing methods that would help alleviate ever-increasing drug shortages, an industry expert told lawmakers.
Across the pond, the UK’s All-Party Pharmacy Group (APPG) has launched a full-scale investigation into ongoing shortages of government-funded prescription drugs.
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