FDA tightens some of its rules. Is greater scrutiny ahead?

Last week, the FDA tightened its rules for prescription cough, cold, or allergy-related medicines. We asked if other medications are at risk for the same scrutiny and if the FDA restrictions would inhibit the development or release of new products.

Ken Evold, PhD, a specialist in the medical device industry with 25 years of experience, says that drug companies that make prescription cough, cold, or allergy-related medications can continue to expect the same treatment they are currently receiving: an intensified review process due to current drug failures. “Medications such as Celebrex, Troglitizone, and Avandia – the list is very long – are on the list of drugs that have failed,” says Evold. “The FDA is responsible and has to answer for their approval reasoning and this is driving the restrictions.”

Evold cites the ReGEN FDA fiasco in the medical device field in 2010 when the FDA approved a knee implant despite significant objections from its own staff. Staff members who were disciplined because of their objections turned into whistle blowers and a top FDA official was found to be too chummy with the company. Incidences such as these have resulted in intensified scrutiny and significantly lengthened the review process of prescriptions medications.

Evold says that he thinks that prices for prescription drugs will continue to rise as companies try to recoup costs for development. “We may also see a continued drop of new drugs approved or even applications submitted,” he says.

By Maureen Aylward

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