Allowing American patients to use medicines approved in Europe would increase regulatory competition, enable more patient choice and potentially save the lives of those suffering life-threatening illnesses who currently have no treatment options, says a new study.
If, during a 12-month period in 2008 and 2009, the US government had allowed American patients to use new medicines that were approved by the European Medicines Agency (EMA) but not yet by the Food and Drug Administration (FDA), American patients would have had faster access to 17 new medicines out of the entire set of 39, according to the report, published this week by the Pacific Research Institute (PRI), a free-market public policy think tank.
During the 12-month review period, the EMA and the 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 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 all 13 medicines approved by the FDA and the EMA, the EMA approved those 97 days faster, on average, says report author John Graham.
It took 18 months, on average, for a new medicine to get US approval in 2008, and American patients are “the innocent victims of the FDA’s regulatory monopoly,” says Mr Graham. “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,” he adds.
In his report, which is entitled Leviathan’s Drug Problem, Mr Graham calls on the US government to amend the Food, Drug, and Cosmetic Act to require the FDA to approve a New Drug Application (NDA) when the drugmaker notifies it that a comparable foreign jurisdiction, such as the European Union (EU), has approved it. The FDA would retain the power the compel manufacturers to label their medicines with the warning that it has not yet approved their safety or efficacy.
After five years, Congress would review how Americans have responded to the lower regulatory costs and faster availability of new medicines which would result from these amendments and introduce further regulatory reform based on that information, Mr Graham proposes. Moreover, he suggests that this review might result in increasing regulatory competition even more by turning the FDA into a “certifier or certifiers,” which would allow private-sector certifiers to compete to assess new medicines.
The report also urges Congress to enact compassionate-access legislation to authorize the Health and Human Services Secretary 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.
Legislation such as the Compassionate Access Act (HR 4732) introduced in the House of Representatives last year by Democrat Diane Watson would allow such patients to try experimental drugs at an earlier phase of regulatory approval than is currently possible, and this would encourage the FDA to use measures other than placebo trials to determine the safety and efficacy of such treatments, says Mr Graham.
