This study concludes 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 in 2008 and 2009, the European Union’s European Medicines Authority (EMA) and the Food and Drug Administration (FDA) approved a total of 39 new medicines. Fifteen were approved only by the FDA, 11 were approved only by the EMA, and 13 were approved by both regulators. In five of the 13 cases where the FDA and EMA both approved the medicine, the EMA was the first to approve, and it issued those approvals 552 days faster than the FDA, on average. Even if we include all 13 medicines approved by the FDA and the EMA, the EMA approved those 97 days faster, on average.
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 new medicines, out of the entire set of 39. Clearly, Congress’s grant of a regulatory monopoly to the FDA is creating a significant obstacle to Americans’ timely access to new medicines.
“Although John R. Graham’s report goes beyond the goals for change at the FDA put forth by the Abigail Alliance, access to a European approved drug would have benefited Alita Randazzo, who was diagnosed with colorectal cancer in 2000. Alita had to travel to France to get the drug Eloxatin, which was not approved by the FDA for another three years. Graham’s analysis brings out that many other patients, who cannot get into FDA mandated clinical trails, 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 for Better Access to Developmental Drugs. “The over paternalistic FDA is not giving people a chance to fight for their lives. As the Abigail Alliance says, the decision to make promising investigational therapies should be that patient’s in consultation with their doctor.”
“It takes an 18-month process, on average, for a new medicine to get through the FDA’s regulatory bureaucracy in 2008. Despite budget and personnel increases, the FDA continues to approve drugs slower than its European counterpart. More money won’t solve the problem of stymied pharmaceutical regulation,” said Mr. Graham.
Prescriptions for Reform
Leviathan’s Drug Problem recommends:
Amending the Food, Drug, and Cosmetic Act to require the FDA to approve a New Drug Application when the drugmaker 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.
“If successful, the two reforms would give the American people confidence that they could free themselves even more from the government’s regulatory burden. American patients are the innocent victims of the FDA’s regulatory monopoly,” said Mr. Graham.