Pharmaceutical Regulation Limits Choice and Puts Lives At Risk

Or so says the Pacific Research Institute (PRI) – a California-based public policy think tank. Earlier this week the group released a report analyzing the deadly consequences of the federal monopoly of pharmaceutical regulation, and proposing alternatives.

The authors conclude that allowing American patients to access medicines that have already been approved in Europe would increase regulatory competition, enable more patient choice, and potentially save the lives of those suffering life-threatening illnesses and who currently have no treatment options.

During a 12-month period from 2008 – 2009, the European Union’s European Medicines Authority (EMA) and the Food and Drug Administration (FDA) approved a total of 39 new medicines. 15 were approved only by the FDA, 11 were approved only by the EMA, and 13 were approved by both regulators. In 5 of the 13 cases where both agencies approved the medicine, the EMA was the first to approve, and it issued those approvals, on average, 552 days faster than the FDA.

The report argues that if the U.S. government had allowed American patients to use new medicines that were approved by the EMA, but not yet by the FDA, American patients would have had faster access to 17 of the 39 new medicines.

The Abigail Alliance for Better Access to Developmental Drugs, a group founded in 2001 by the father of a 21 year old girl denied access to life-saving treatments, agrees with the findings of the report.  “Patients, who cannot get into FDA mandated clinical trials, would benefit from the U.S. government’s recognizing European approval of lifesaving and life-extending new drugs.” said Frank Burroughs, President of the Abigail Alliance. “The over paternalistic FDA is not giving people a chance to fight for their lives. The decision to make promising investigational therapies should be that patient’s in consultation with their doctor.”

The PRI report recommends:

  • Amending the Food, Drug, and Cosmetic Act to require the FDA to approve a New Drug Application when the drug-maker notifies the FDA that a comparable foreign jurisdiction, such as one in the EU, has lifted its ban on the new medicine.
  • Enact the Compassionate Access Act, H.R. 4732, a bill that would authorize the Secretary of Health and Human Services to permit an unapproved drug to be made available under certain conditions if a patient is seriously ill, has exhausted other treatments, and is ineligible for a clinical trial for various reasons.

For more on this story click on the video link.

Let us know what you think about the drug approval process.  Too fast, too slow? Is the FDA being overly cautious, as the authors suggest, or should the Agency be even more stringent.  SRxA’s Word on Health looks forward to hearing from you.