FDA Cracking Down On Unapproved Drugs, Devices

05/11/2009 05:12 am ET | Updated May 25, 2011

The Food and Drug Administration may be getting some teeth.

According to the Associated Press, the FDA said Friday it secured a court order barring a New Jersey-based pharmaceutical company from distributing unapproved cough and cold medicines.

Advent Pharmaceuticals and its subsidiary, Neilgen Pharmaceuticals, marketed more than 50 medications, including P Allergy Junior Suspension and RE All 12 Suspension, without submitting them first to the FDA for approval, it said. The companies also failed to correct manufacturing problems identified by FDA inspectors.

The move comes as the FDA ramps up efforts to crack down on unregulated medicines and devices. On Wednesday, the regulators asked certain medical device companies to prove that their products were safe an effective, according to the New York Times.

The renewed effort to review products stems in part from a Government Accountability Office report released in January that criticized the agency for failing to do enough to ensure the safety and effectiveness of devices.

According to the report, the FDA has yet to fix its system for reviewing categories of medical devices that have been on the market since before 1976, when a new medical device law was passed.

According to the New York Times:

Such legacy devices, as they are known, were originally allowed on the market with minimal testing. But in the 1976 law Congress told the F.D.A. to gradually reclassify these older devices and decide which ones needed extensive testing before approval of new versions and which ones did not.

The agency never finished that process, leaving 27 different types of devices unexamined -- products that include artificial lung membranes, external defibrillators and various pacemaker components.

As for Friday's move against Advent and its drugs, the FDA advised that consumers discontinue using the medications and "discuss FDA-approved treatments with their health care professional."

Advent company executives Bharat Patel and Pragna Patel agreed to destroy their inventory of unapproved drugs, under a consent degree handed down in the U.S. District Court of Maryland. The agreement also bars the executives from manufacturing any new drugs without FDA approval and requires them to hire outside consultants to assess their operations before resuming production.

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