Astonishing as it might sound, a major, complex and important health care bill is making its way through Congress with broad bipartisan support. The legislation was on track to be completed this month but has hit a snag over differences between the House and Senate versions.
The legislation is called the Prescription Drug User Fee Act, and it sets the ground rules for a novel program designed to get new medical treatments to patients faster and more efficiently.
PDUFA would continue a 20-year-old program in which pharmaceutical, medical device and biotech companies pay user fees so that the Food and Drug Administration can hire the experts it needs to review applications for approval for new medicines and medical devices.
The PDUFA legislation has a five-year time period and will expire this year unless Congress renews it. If it fails to do so, the FDA would lose a significant portion of its funding for drug and medical device review.
The Senate committee reviewing the legislation approved it in April by a strong bipartisan majority, but work on companion legislation in the House was interrupted over several questions, primarily involving economic development, that are tangential to the central goal of the legislation.
The industry wants to continue the PDUFA program so that its medical products can get to patients as quickly and as safely possible, but they can’t continue to pay the fees without commitments from the government that they will be spent for the designated purpose.
In the early 1990s, it was clear that the FDA was overwhelmed and understaffed in dealing with increasingly complex medical applications.
The industry was frustrated over severe delays in review times that interfered with getting new medicines to patients.
In response, Congress passed the first PDUFA law in 1992 that gave the government the authority to collect user fees from the biomedical industry, providing the FDA with a steady stream of revenue to improve and expedite its review processes.
Since then, product review times have declined markedly, from 30.2 months in 1991 to less than 13 months in 2007. More than 1,500 medicines and medical devices have been approved since PDUFA was first enacted.
Partially as a result, the United States now leads the world in the development of new medicines. For example, in an industry once dominated by European firms, 12 of the top 20 medical device companies are now headquartered in the United States.
Not only are lifesaving drugs more readily available, but our economy also benefits from the success of the pharmaceutical and other health sector firms that invest in research and jobs. According to a study from Battelle, the well-known science and technology research firm, the biomedical industry contributed an impressive $917 billion to the U.S. economy in 2009 and supported more than 4 million jobs.
Congress already has passed PDUFA four times. Each time, the law’s basic structure has remained in place, but Congress has also used the legislative negotiations to raise the bar on the FDA regulatory oversight and to mandate more stringent performance goals.
Unfortunately, these additional provisions have clogged the process, creating new delays. Between 2003 and 2007, FDA approval times averaged 13 months. In 2008, under the latest version of PDUFA, review times rose 28 percent to an average of 16.2 months. Fewer than half of new applications were approved during their first submission cycle.
The current reauthorization process offers an opportunity to correct these negative trends while adding transparency and efficiency back into the process.
But consumer groups are pushing to add even more requirements in the latest version of PDUFA. They want Congress to mandate, for example, that drug companies undertake “comparative effectiveness” studies prior to the approval of a new drug. That would add many months and tens or even hundreds of millions of dollars to the cost of bringing a new drug to market, expenses that would add to the cost of new drugs.
A regulatory model that provides drug companies with transparency, clarity and certainty is essential to innovation. Congressional reauthorization of a clean PDUFA bill will ensure that lifesaving medicines get to the patients who need them in a timely manner. Other issues can wait for a more thorough and focused debate.
Grace-Marie Turner is president of the Galen Institute.