FDA’s Critical Path Initiative Gets Mixed Results, Mixed Reviews

Published March 1, 2009

Nine out of 10 Americans support the ideas behind the Food and Drug Administration’s Critical Path Initiative, a federal program designed to streamline the drug development and approval process, according to a survey conducted by the Center for Medicine in the Public Interest.

FDA launched the initiative in 2004 to reverse an ongoing slowdown in the number of innovative drugs and therapies reaching patients.

FDA has encountered several speed bumps in its attempts to unclog the drug development pipeline, but the Critical Path Initiative remains extremely popular with the American public as a whole, the survey notes.

“Day in and day out, Congressional lawmakers bash the FDA,” said CMPI President Peter Pitts. “That may score political points, but the public’s support for this program should send a strong message to Congress: Don’t cut funding from the Critical Path Initiative.”

FDA’s Process Questioned

Whether because of overly strict clinical testing standards by FDA or what an agency report called a failure of “the medical product development process” to “keep pace with basic scientific innovation,” the “vast majority” of new drugs that entered clinical trials since 2000 have failed to gain approval, often after a great deal of time and capital had been invested in their discovery and development, according to the agency.

In the 1990s, the average number of drugs approved annually doubled from 20 at the beginning of the decade to 40 in 1998, as the result of scientific advances and significant improvements to FDA’s approval process. By the early 2000s, however, that momentum was lost, and by 2004 the lowest number of new medical therapies in 20 years made it through the FDA process and onto the market.

Michael Cannon, director of health policy studies at the Cato Institute, attributes the decline in product submission to the agency’s process. Cannon cites what he sees as FDA’s “institutional inability to strike a proper balance between speed and caution.”

“The FDA’s drug-approval process costs lives by requiring too much time and testing before a drug can be brought to market, and we would be better off without it,” Cannon said.

FDA Initiated Changes

The failure rate of products submitted for FDA approval has further increased growing R&D costs, which means “developers are forced to use the profits from a decreasing number of successful products to subsidize a growing number of expensive failures,” according to FDA.

To address the problems, FDA administrators in 2004 suggested public and private participants in the development process engage in a “collaborative effort to create a new generation of performance standards and predictive tools,” using new biomedical science to “modernize the critical path.”

Advances in bioinformatics, genomics, imaging technologies, and materials science were to be harnessed by the initiative, spearheaded by FDA, which would be responsible for “identifying and prioritizing” issues clogging the drug development pipeline and opportunities for improved public health benefits.

Under the Critical Path Initiative, FDA strived to modernize its regulatory and communication infrastructure in small ways, such as creating a portal for the electronic transfer of product information and standardizing the electronic submission of proposed prescription drug labels. However, a great deal of room for improvement remained, analysts noted.

Evaluating the Program

At the program’s two-year mark, in March 2006, FDA issued an evaluation of the Critical Path Initiative acknowledging major shortfalls in the process, including one major purpose of the program from its inception—facilitating the development, submission, approval, and distribution of new drugs and biomedical devices.

According to the March 2006 FDA report, “a new compound entering human trials in 2000 was no more likely to reach the market than one entering human testing in 1985.”

In 2007, FDA approved only 17 “novel molecular entities,” or new drugs. This tied 2006 for the lowest number of newly approved drugs since 1983. Explanations included a risk-averse mindset among developers, a dearth of recent scientific breakthroughs, and an industry that “has shifted its focus away from novel drugs and toward tweaking existing medicines to maximize sales during the research drought,” said Jacob Goldstein, health care policy reporter for The Wall Street Journal.

Submissions Decreasing

Another agency report found the “development path” of drug and biomedical devices was “becoming increasingly challenging, inefficient, and costly.”

The problem, FDA administrators determined, was largely due to a decrease in the number of innovative medical products being submitted to FDA for approval. Yet between 1994 and 2003 funding for biomedical research nearly tripled (from $37 to $94 billion) in the United States alone, according to agency figures, with 57 percent of that total coming from the private sector.

Jeff Emanuel ([email protected]) is research fellow for health care policy at The Heartland Institute and managing editor of Health Care News.

For more information …

“CMPI Report on the Critical Path Initiative,” Center for Medicine in the Public Interest: http://www.cmpi.org/PDFs/Reports/CMPIReportOnCriticalPathInitiative

“Innovation Stagnation: Challenge and Opportunity on the Critical Path to New Medical Products,” U.S. Food and Drug Administration: http://www.fda.gov/oc/initiatives/criticalpath/whitepaper.html

“Innovation Stagnation: Critical Path Opportunities Report,” U.S. Food and Drug Administration: http://www.fda.gov/oc/initiatives/criticalpath/reports/opp_report.pdf