Executive Briefing Series (formerly The Food & Drug Letter)

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manufacturing interruptions and delays in acquiring raw materials to help prevent drug shortages, the agency says in draft guidance published in the Feb. 27 Federal Register.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.