FDA's activist

The last thing most observers expected from George W. Bush was an activist healthcare agenda, but it is becoming clear that his administration, particularly if it is extended by another four years, will have a profound impact on the regulatory terrain. The administration's biomedical regulatory agenda is activist in the sense that it is expanding the scope of government intervention, and it is being crafted and implemented at arm's length from industry.

Contrary to expectations from the presidential campaign and the first few months of the administration, the major medical policy transformations under Bush aren't related to stem cells, contraceptives or abortion. Although both medical research advocates and anti-abortion activists are disappointed and angered by current U.S. policies on embryonic stem cells and research cloning, the Bush compromise allowing federally funded research using embryonic stem cells created prior to August 2002 has effectively taken the issue off the table. The President's Council on Bioethics has had little discernable influence on policy, and Republican medical research supporters in the Senate have prevented enactment of legislation banning therapeutic cloning.

Instead of focusing on the conservative social agenda, the Bush administration is laying the groundwork for changes in the ways medical technologies are researched, developed, regulated and reimbursed. The new policies are attempting to address goals that are difficult to reconcile: removing impediments to innovation, increasing access to medicine, and muting the crescendo of complaints about rising healthcare costs.

In addition to the tectonic changes to the drug development landscape that the addition of a Medicare outpatient prescription drug benefit will provoke, biotech will have to adjust to the expanded missions envisioned by the heads of the Centers for Medicare and Medicaid Services (CMS) and NIH. CMS Administrator Tom Scully's aggressive cost-cutting policies have made Medicare reimbursement the final goalpost for many of the most expensive new biotech products. At the front end of the government's involvement with biopharmaceuticals, Elias Zerhouni has taken over the NIH following a period of unprecedented increases in biomedical research budgets, and is focusing on the modernization of clinical research procedures and emphasizing the translation of basic research into medicines.

The most ambitious plans for changing the regulatory environment, however, are being developed at the FDA, an agency that has not attracted attention from Congress or public policy think tanks commensurate with its scope of responsibilities. Although FDA Commissioner Mark McClellan is an M.D., he is also an economist, and he is clearly imposing an economist's imprint on the agency.

In an extensive interview with BioCentury, McClellan described plans for stimulating innovation, reducing the cost of developing biopharmaceuticals, and increasing the predictability of a range of interactions between manufacturers and FDA. He said the agency will move beyond the specific goals stipulated under the Prescription Drug User Fee Act and will benchmark its success against improvements in the total elapsed time and cost to take a drug candidate from discovery to commercial distribution.

FDA soon will release a strategic plan that will detail its plans for

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