NCPA - National Center for Policy Analysis

The FDA Cannot Effectively Monitor the Medicine Supply System

July 11, 2014

Most Americans expect that the Food and Drug Administration (FDA) would regularly test batches of imported drugs to ensure quality, but that is not the case, explains Roger Bate, resident scholar at the American Enterprise Institute

In fact, a number of Indian pharmaceuticals have been withdrawn from the U.S. market due to problems:

  • Indian generic drug manufacturer Dr. Reddys Laboratories withdrew 13,560 bottles of generic Toprol, a blood pressure medicine, due to solubility problems. Wockhardt Ltd. also withdrew 109,744 bottles of the same drug.
  • In March, Dr. Reddys Laboratories recalled about 58,000 bottles of another drug, lansoprazole, due to contamination.
  • In May 2013, Ranbaxy, a large Indian drug firm, was found guilty in an American court of seven felonies and fined for lying about quality lapses for the last 10 years.

Scientists and doctors regularly report safety concerns to the FDA based when they receive negative feedback from patients.

  • When Dr. Harry Lever of Cleveland told the FDA that there was a problem with a blood pressure medicine, the FDA told him that everything was fine with the drug. But shortly thereafter, Dr. Reddy's, Wockhardt and other Indian drug producers withdrew the drug from the market.
  • When Dr. Preston Mason raised concerns to the FDA that a generic version of Lipitor contained impurities, the FDA ignored his findings and suggested he contaminated his samples.
  • It was only through whistleblowers, Bate notes, that the FDA was able to discover problems with Ranbaxy's drugs.

Bate writes that the FDA needs new policies in order to ensure the quality of imported drugs. He suggests that the agency publicly publish the data received from generic drug companies indicating that their generic products have "bioequivalence" (in short, that they work the same as the original product). Additionally, he encourages the agency to conduct its own quality assessments. By giving this data to doctors, physicians can decide which generic is best for their patients.

Until some sort of reforms are in place, Bate writes, the FDA cannot ensure that all products entering the American market are safe and effective.

In related news, the National Center for Policy Analysis recently published a report on India's lack of intellectual property right enforcement and its strain on pharmaceutical trade between India and the United States.

Source: Roger Bate, "Time To Open The FDA's Black Box," Daily Caller, July 1, 2014.


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