Alex Philippidis Senior News Editor Genetic Engineering & Biotechnology News

The agency will take at least another year to flesh out plans.

The loudest complaints directed at the FDA by life science leaders in recent years have been related to its increasingly complex process of reviewing new drugs and medical devices. Intent on avoiding another debacle like the deaths, heart attacks, strokes, and other side effects linked to blockbuster medications like Celebrex and Vioxx, the agency has swung the proverbial pendulum in the opposite direction, slowing the pace of reviews and, in many cases, increasing the time and money needed to bring drugs to market.

The average combined clinical development and approval time for biopharmaceuticals has lengthened by a year and a half; in the decade of the 2000s the time required was 95 months, while in the 1990s it was 77 months, according to the Tufts Center for the Study of Drug Development. And while the number of biopharma products in the 2000s (65) was nearly double that in the ’90s (39), drug developers will be hard pressed to maintain that pace going forward, noted Janice Reichert, Ph.D., research assistant professor at Tufts University and author of a study released by the center earlier this month.

Through its “Strategic Priorities 2011–2015: Responding to the Public Health Challenges of the 21st Century,” FDA sought to convey a message to drug developers that relief is on the way. But many of the priorities and initiatives to achieve that relief, which was highlighted in the 50-page report, are more than a year away.

Priorities range from the sensible (“establish an effective tobacco regulation, prevention, and control program”), to the obvious (“manage for organizational excellence and accountability”), to the basic (“advance food safety and nutrition” and “promote public health by advancing the safety and effectiveness of medical products”).

Improving Drug Review

The medical products safety and effectiveness initiative included some reassuring goals such as “protect public health by ensuring the quality and integrity of marketed drug products,” and “protect public health by promoting the safe use of marketed drugs.” However, while the report identifies efforts to address these issues, it doesn’t get into details about the solutions since the answers are being developed.

Take the drug review process, for example. The report highlights, in two paragraphs, the Quality Systems Framework being developed by the agency’s Human Drugs Program. Its purpose is to “address operating issues such as drug reviews, adverse events reviews, and other activities,” Raymond Formanek Jr., a senior advisor at FDA, told GEN. “Currently under development, the Quality Systems Framework will be pilot-tested later this year and posted some time in 2012.”

FDA offers three fairly basic strategies for achieving its goal of ensuring the availability of safe and effective new drugs:

• Identify and develop new scientific methods, models, and tools to improve the quality, safety, predictability, and efficiency of new drug development.

• Conduct rigorous science-based premarket review to ensure that drugs that will be marketed to the public are safe and effective.

• Ensure patient awareness of drug benefits and risks through effective communication of drug information.

Several of these components, however, won’t emerge for another five years, by FDA’s projection. The agency said that it has begun identifying strategies to recruit and retain outstanding scientists. It will work collaboratively to define and advance science in high-priority areas.

Dealing with Emerging Technologies

“The agency charged with judging the safety and effectiveness of drugs and other medical products and monitoring the safety of those products as long as they are on the market must possess a scientific capability equal to that task and become engaged in mission-critical fields of applied research including systems biology, wireless healthcare devices, nanotechnology, medical imaging, robotics, cell- and tissue-based products, regenerative medicine, and combination products,” the report declared.

FDA will take one of its first steps in that direction next year, when it rolls out details of another key life science priority: “Strategic Priorities 2011–2015 calls for keeping up to date in new technologies while maintaining expertise in established technologies.” On this topic, at least, the report offers some more concrete thinking by the FDA.

The agency said it will “integrate genomics, proteomics, high-sensitivity gene sequencing, and other cutting-edge technologies into regulatory oversight to expedite product development and review.” Additionally, the agency said it will also use biomarkers and adaptive designs to improve its evaluation of product effectiveness in clinical trials and advance regulatory research to facilitate product review including developing relevant animal models.

“FDA will continue to work in a collaborative manner with our public, academic, and private-sector partners to meet the challenges posed by the emerging technologies,” Formanek said.

Overcoming those challenges, according to the agency, will require unspecified “program growth in emerging areas such as nanotechnology, biosensors, proteomics, genomics, and metabolomics.” Fair to say “program growth” means some combination of extra activity, personnel to carry it out, and of course the money to pay for it. But that growth will be easier said than done.

Achieving Balance

While FDA fared better than many other agencies in this year’s budget agreement for FY 2011, it still faces the prospect of tight budgets for the next several years. The reason: Congressional Republicans and Democrats have tied approval of the fiscal year 2012 budget to an agreement to curb federal spending and reduce the trillion-dollar annual deficits.

President Obama proposed appropriating $2.74 billion for FDA, up from the $2.452 billion approved for FY 2011 last month and $2.345 billion in FY 2010. The agency also receives about $1 billion annually in user fees paid by companies seeking approvals.

A key reason FDA saw its budget grow this fiscal year: increased responsibilities wrought by the most ambitious regulations pertaining to the agency in its near-century of existence. The Food Safety Modernization Act (FSMA), enacted by President Obama in January, is designed to shift the focus of federal regulators from responding to contamination to preventing it.

“The agency’s centers and offices currently are working on plans on how to meet the goals outlined in the strategic priorities document. Details on those plans will be available early in 2012,” Formanek said.

FDA’s strategy will have to account for a deficit-reduction plan whose details have yet to be written. Life sciences leaders will watch the Quality Review Framework closely over the next year to see how well it balances the need for drug safety and effectiveness with the need to streamline an ever-lengthening clinical-trial and drug-review system. It’s a balance that, more than anything else, should remain FDA’s top strategic priority over the next five years.

Alex Philippidis is senior news editor at Genetic Engineering & Biotechnology News.

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