St. Louis Business Journal -- Kevin Buckley, head of the life science practice at the Clayton office of law firm Spencer Fane Britt & Browne, is looking forward to the U.S. Food and Drug Administration expanding its staff -- something that should speed up its review process for new drugs. “The length of time for reviews impacts all pharmaceutical companies,” said Buckley, who represents small and midsize ones. And, as the FDA review gets more rigorous to ensure drugs are safe, the process drives up costs for small and big companies alike, he said.
“The more people you can get to analyze the (clinical) data at the FDA, the better. It should make the process become much faster,” Buckley said.
Established pharmaceutical companies such as Pfizer Inc., which has research facilities in Chesterfield, has 1,256 studies in clinical trials, including 67 in Missouri. Successful trials can take a decade and cost $1 billion or more, Dan Getman, Pfizer’s vice president of global research and development in St. Louis, recently told the Business Journal.
Other drug discovery firms with connections to St. Louis -- such as Covidien, known as Tyco Healthcare until its spinoff from Tyco International last year, which has 13 clinical trials -- face the same lengthy and expensive drug approval process.
Buckley, Getman and others involved at some point in the pipeline of new pharmaceuticals are relying on an FDA initiative announced earlier this year to hire 1,317 scientists within the next few months -- 770 are new positions and 547 are unfilled jobs, said Christopher Kelly, a spokesman for the agency in Washington, D.C.
Questions on the FDA’s funding and staffing have been raised before, indeed by the FDA itself, which has also questioned the review process.
Dr. Andrew von Eschenbach, commissioner of the FDA, described it in a June 10 address to the Commonwealth Club of California, which hosts public affairs forums: “This process has served us well in the past but it is slow, laborious, and fraught with failure and, most importantly, exposes thousands of patients to drugs and medical devices before they are proven to be safe and effective,” he said, as he proposed modernizing the process.
To meet its ambitious goal to hire more biologists, chemists, medical officers, mathematical statisticians and investigators, the FDA is holding job fairs around the country, none in St. Louis. The next job fair is Aug. 21 in Washington, D.C.
When the initiative ends Sept. 30, the FDA expects to have about 11,000 total employees. Of those it hires, about 500 positions will be paid for through user fees, spokesman Kelly said. Pfizer and other drug companies pay to have their drugs reviewed as part of the Prescription Drug Use Fee Act, which has been around since 1992. Those fees are budgeted at $628 million for the 2009 fiscal year, a $79 million increase from the current, 2008 year.
John McKearn, a partner with RiverVest Venture Partners in Clayton, which backs early-stage drug development companies, also praised the FDA’s staff expansion as a positive step. The agency had lost many of its talented researchers over the last few years, when they moved to private industry where they are paid better, said McKearn and Buckley.
FDA budget boost
The FDA, whose mission includes keeping the country’s food supply safe as well as approving new and modified applications for pharmaceuticals, faced challenges on both fronts this year. It is still hunting down the source of a salmonella outbreak that hit 43 states, and the source of a fatal contamination to the blood thinner heparin involving materials manufactured in China.
In June, the U.S. Department of Health and Human Services, which oversees the FDA, amended its budget request for the FDA to include an additional $405 million for the the agency in next year’s budget. The bill had support of both Missouri senators, Kit Bond and Claire McCaskill.
“As the FDA continues to face new challenges protecting our nation’s food and drug supply, it is important that Congress provide them with the resources they need,” Bond said in a statement.
McCaskill’s press secretary, Maria Speiser, said reports from government administrative offices and congressional committees have found that the FDA has been chronically underfunded, which prompted McCaskill to support the funding increase.
The increase boosted the administration’s total proposed FDA budget for fiscal 2009 to $2.7 billion, a 17.8 percent increase in funding from fiscal 2008. The largest share of the increase is going toward protecting the country’s food supply. Part of it is to be used to modernize the FDA scientists and work force to handle emerging sciences, including cell and gene therapies and genomics.
RiverVest’s McKearn pointed out that the Prescription Drug Use Fee Act, which has been revised several times since its inception 16 years ago, provided roughly $260 million to the FDA for its new-drug and new-device reviews in 2007. According to the U.S. Government Accountability Office, the act has allowed the FDA to increase the number of drug reviewers by 77 percent and reduce the median administrative review time from 27 months to 14 months. However, McKearn said as the FDA beefs up its reviews for safety, there is concern whether the FDA staff will be able to keep up the momentum.
Drs. Benjamin Schwartz and Laurel Mengle-Gaw, cofounders of the clinical development business Camden Group in St. Louis, worked on G.D. Searle’s (now Pfizer’s) blockbuster arthritis drug Celebrex. They said a factor complicating FDA reviews is the sheer size of clinical trials needed to establish the safety and effectiveness of new drugs. The larger trials allow companies to learn more about the safety and side effects of such drugs. At the same time, they said, gathering and deciphering all the information from such large tests can add months to the process.
Those longer reviews potentially eat into the 20-year patent life of a new drug, even with patent extensions allowed under existing law, Buckley said.
Big and small companies are looking for more effective ways to produce research the FDA requires. More pharmaceutical businesses are turning to third-party specialists, contract research organizations such as SeventhWave in Chesterfield or ABC Laboratories Inc. in Columbia, Mo. “These companies can handle the clinical research more efficiently,” Buckley said.
