New Year, New Policy Challenges for Pharma - Pharmaceutical Executive


New Year, New Policy Challenges for Pharma
Pricing, safety, comparative effectiveness, patents, and biosimilars top 2008's policy agenda

Pharmaceutical Executive

Protecting Patents?
Amidst the outcry over inadequate foreign inspections, FDA continues to struggle to meet requirements for monitoring pharmaceutical plants in the United States. The agency's field force has suffered from budget cuts, and recent reorganization plans have been derailed by opposition from regulatory staffers and from Congress. Perhaps demands to boost oversight of imports will increase support for domestic regulatory activities as well.

The push on drug pricing Despite concerns about hazardous medicines from overseas, some members of Congress continue to press for more liberal drug-reimporting policies to help consumers access low-cost medicines. Medicare Part D has greatly expanded government outlays for prescription drugs, and everyone wants to keep the drug spend under control. Democrats claim that government authority to negotiate payments for Medicare drug plans will help, as will full disclosure of manufacturer prices, curbs on drug advertising, and expanded access to low-cost generic drugs.

To achieve this last goal, Congress will continue to seek a pathway for FDA to approve follow-on biologics. The legislators agreed to drop that issue from FDAAA, but promised to take it up this year. And projections of big cost-savings from biosimilars will keep it on the front burner.

Comparative effectiveness analysis Better information on which medical treatments work best for certain patients could improve healthcare and cut spending by reducing inappropriate drug utilization and avoiding unnecessary or harmful procedures. That possibility is boosting support for a larger government role in assessing medical-treatment effectiveness, while health plans and payers also demand more evidence that medical products are cost-effective as well as safe and effective medically.

The challenge for drug and medical-product manufacturers is to encourage analysis of how drugs compare with alternative medical and surgical procedures—and not to use this information to control prices or deny coverage for innovative products. Even if a study indicates that a drug may be less effective for many patients, there should be room to prescribe that drug for a smaller patient population that may benefit.

Curbing conflicts of interest More independent assessments are needed because some members of Congress and consumer advocates believe that pharma exercises too much control over FDA decisions. The critics want to block scientists with industry ties from serving on FDA advisory boards, but agreed to a FDAAA compromise that allows some conflict-of-interest waivers so that important experts will be able to provide advice when needed. FDA has issued new policies to make COI and waiver policies more transparent and is taking steps to reduce waivers overall.

Concerns about industry influence at FDA have colored the formation of the new Reagan-Udall Foundation, created by FDAAA to support innovation and enhance safety for FDA-regulated products. FDA named a 14-member panel, headed by former FDA commissioner Mark McClellan, to oversee the new organization. But Rep. Rosa DeLauro (D-CT), who chairs the House Appropriations subcommittee in charge of FDA's budget, has objected that industry influence may lead the foundation to encourage the development of more profitable, but not necessarily safer, products.

DeLauro plans to hold hearings on Reagan-Udall and other COI issues, while also directing how FDA spends its annual budget. Sponsors have joined with the biomedical research community and other parties to urge a significant boost in agency resources so that FDA can better manage its continually expanding responsibilities. A new report to FDA's Science Board says that the agency needs more money and better computer systems to keep up with important scientific advances and adequately protect the nation's health [see "Show FDA the Money"]. It's not clear whether Congress will respond to this challenge or if this expert analysis will just gather dust on the shelf like so many similar undertakings.

Jill Wechsler is Pharmaceutical Executive's Washington correspondent. She can be reached at


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