By Stephen Spotswood
WASHINGTON — What should FDA’s role be in the continuing globalization of the prescription drug market, and should the agency be obligated to consider the health of the American pharmaceutical industry in any decisions it makes?
Those questions are being debated by Congress as the FDA negotiates with industry representatives to craft new versions of the current Prescription Drug User Fee Act (PDUFA) and Medical Device User Fee Act (MDUFA), which expire next September.
An agreement was reached on PDUFA shortly before the new year and, according to FDA officials, an agreement recently was reached on MDUFA. The latter will need to be published and opened to public comment.
Of the $931 million obligated last year in support of the drug-review process, PDUFA fees funded 62% of it, with the remainder funded through appropriations. The new agreement, if passed, would have industry paying $700 million in fees in FY2013, with higher amounts in the remaining four years of the five-year legislation.
These fees would help FDA increase communication with drug sponsors, building contacts and meetings during the regulatory-review process to give industry a quicker, easier process. This includes a new 60-day validation period that will be used by FDA and sponsors to communicate, interact and plan before the clock officially starts on the regulatory process.
According to FDA, sitting down early with manufacturers will ensure that all of the players understand where they are in the process and what is expected of them, thus avoiding unnecessary delays or confusion.
While this change is designed to strengthen oversight, some Republican congressmembers have questioned whether overregulation creates delays and regulatory road bumps that send industry oversees.
In a recent hearing of the House Energy and Commerce Health Subcommittee, Chairman Joe Pitts (R-PA) asked FDA Commissioner Margaret Hamburg, MD, whether FDA should be doing more to secure American jobs.
“Shouldn’t we ensure that our regulatory system doesn’t create an uneven playing field for manufacturers?” he asked. “Wouldn’t a risk-based inspections approach make more sense in ensuring resources are spent inspecting high-risk facilities [rather] than the use of statutory requirements?”
Hamburg said FDA definitely needs to rethink many of the ways the agency traditionally has done business.
“Many of our authorities were put in place in a world that looked very different,” she said. “At that time, most drugs were produced in this country. We’re trying to increase our ability to do inspections internationally [including] looking at a risk-based approach.”
Currently, approximately 40% of drugs used by Americans are manufactured outside of the U.S., and 80% of active ingredients in those drugs come from foreign sources.
The title of the subcommittee hearing was “Reauthorizing PDUFA: What It Means For Jobs, Innovation, and Patients.” Some legislators argued, however, that it is not part of FDA’s mission to consider whether the agency’s decisions will impact jobs.
Rep. Henry Waxman (D-CA), ranking Democrat and former full committee chairman, stated that he does not see job promotion as one of FDA’s responsibilities.
“I hope that FDA does not take jobs into consideration when reviewing the safety and effectiveness of new medicine,” Waxman told his fellow representatives. “We want to make sure drugs are safe and effective. Job growth shouldn’t be part of the question. In fact, some of the new drugs, if they are higher priced, may be a financial burden. [But considering that] is also not FDA’s appropriate role.”
Waxman also argued that, while there is continuing rhetoric from the Republicans on the committee that FDA is too demanding of the industry and that regulation has resulted in job loss and innovation being driven abroad, there is no hard evidence of this.
“When we examine claims as serious as these, we must insist on data and facts,” he said. “Biases and anecdotes from individual companies do not consist as facts.”
According to Pitts, the committee would like to see the two acts reauthorized by the end of June and not wait until the last minute, as has occurred with previous reauthorizations. This would be the fifth reauthorization for PDUFA and the third for MDUFA.