The Food and Drug Administration just held its first public meeting to set the course for the future regulation of prescription drugs and medical devices in this country.
Every five years, Congress must reauthorize the Prescription Drug User Fee Act (PDUFA), which governs many of the FDAs regulatory efforts. Some lawmakers hope to use the debate over PDUFA to streamline the agencys review process and thus to get innovative, life-saving treatments to patients faster.
Legislators are right to do so. The FDAs longstanding aversion to risk and penchant for regulatory overreach are keeping many revolutionary remedies from American patients.
PDUFA was implemented two decades ago to speed up the FDAs sluggish review process. The law gives the agency the power to charge device manufacturers and others anywhere from $100,000 to $2 million to review their products. These fees fund nearly 25% of the FDAs total budget.
Many patient advocates, members of Congress and of course, drug- and device-industry reps have chided the agency for its sloth despite all that additional funding.
Regulators have bristled at these accusations. At a conference in October, Janet Woodcock, a senior FDA official, suggested that Congress was in a blowing up mood and might go overboard with reform efforts. Other officials have tried to downplay concerns about the agency and stated that it could handle reforms internally.
But a little bit of regulatory blowing up is exactly what the FDA needs.
Consider the FDAs device review process. The agency screens medical devices far more slowly than does its counterpart in the European Union.
European officials erect fewer hurdles for manufacturers to clear. For one thing, EU rules focus on safety, not efficacy. So doctors and patients not bureaucrats are empowered to decide whether a device is worthwhile.
The European system also does not require device manufacturers to get permission before marketing a device. The United States, in contrast, forces the medical-device industry into a government-run, mother-may-I system.
And the problem is getting worse. According to a 2011 study published by the California Healthcare Institute, the FDAs reviews for higher-risk medical devices are now taking 75% longer than they did between 2003 and 2007.
According to a study coauthored by Josh Makower, a professor of Medicine at Stanford University, patients in America must wait two full years longer, on average, than those in Europe for medical devices to hit the market.
California patient advocate Marti Conger knows this reality all too well. In testimony before Congress earlier this year, Conger spoke of a severe and unusual spinal condition that surfaced in her body in 2006 and the lack of treatments available to her in America.
The artificial disc she needed had not yet been approved by the FDA but had been available since 2005 in Britain. Fearing for her health, Conger decided to empty her savings and travel to England for the disc replacement procedure.
And by slapping a new 2.3% tax on device makers, Obamacare is making the situation even worse. The device industry is preparing to cut jobs in the United States and grow outside the country. According to a study by the industry group AdvaMed, the device tax alone could cost the industry more than 10% of its jobs, slashing some 43,000 positions. Some 87.5% of device makers expect growth to be higher outside America in the coming years.
The FDA also serves Americans poorly with respect to prescription drugs. Although the FDAs budget and headcount have increased dramatically, its productivity has deteriorated, according to a study completed by my colleague John R. Graham. During a twelve-month period in 2008-2009, thirteen new medicines were approved by both the FDA and the European Medicines Authority (EMA) but the EMAs approvals came 552 days faster, on average.
The FDA may believe that its review processes are working just fine. But the facts speak otherwise. Congress must seize the opportunity before it to streamline Americas system of medical regulation.