Biotech Manufacturers Face a Challenging 2008 - FDA and industry must contend with new safety policies, pricing concerns, and pressure to innovate - BioPharm International

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Biotech Manufacturers Face a Challenging 2008
FDA and industry must contend with new safety policies, pricing concerns, and pressure to innovate


BioPharm International
Volume 21, Issue 1

The challenge for drug and biotech manufacturers is to focus such analysis on how medicines compare to alternative medical and surgical procedures, and to avoid using comparative assessments to control costs or to 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 product for a smaller patient population that may benefit.

• Revising patent policy. Congressional leaders seek to enact sweeping patent reform legislation that its supporters believe will better protect intellectual property and bring US policy more in line with that of other nations. Software and IT firms support the legislation as likely to reduce their exposure to endless litigation, but biotech and pharmaceutical companies fear a serious erosion of patent protection and reduced value for patent awards.

A main issue is a proposed post-grant review system that allows re-evaluation of patents after they are awarded, but could create considerable uncertainty about the value of biotechnology patents and expose the system to abuse. Difficulties in reaching compromise on these issues has delayed legislative action, but key members of Congress will seek to finalize the bill this year.

• Spurring innovation. In order to bring new therapies to market more efficiently, FDA is working with industry to develop new methods for testing and assessing drug safety and efficacy. The agency's Critical Path Initiative encourages public–private partnerships to develop new biomarkers, assess drug quality issues, and explore new approaches for ensuring product safety. An important project aims to improve methods for assessing liver toxicity in preclinical testing. FDA recently launched a collaboration with Duke University Medical Center to streamline clinical trial operations through electronic data standards, updating review board policies, and establishing accreditation program for clinical investigators and research sites. Other initiatives aim to improve assessment of medical product bioequivalence and for complex drug product characterization.

FDA also continues to promote new approaches for ensuring drug quality in the US and abroad. The International Conference of Harmonization is finalizing guidelines to help manufacturers establish quality systems based on an integrated approach to quality risk management. Companies that adopt Quality by Design and good risk management strategies stand to gain from reduced postmarketing oversight of manufacturing changes and less intensive plant inspections.

• Curbing conflicts of interest. Some members of Congress and consumer advocates want to keep scientists with industry ties from serving on FDA advisory boards. FDAAA 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 conflicts of interest and waiver policies more transparent and is taking steps to meet Congressional requirements for reducing waivers overall.

Concerns that drug manufacturers exercise too much control over FDA policies has emerged related to the composition and role 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, chaired by former FDA commissioner Mark McClellan, to oversee the new organization. But Rep. Rosa DeLauro (D-Conn), who chairs the House Appropriations subcommittee in charge of FDA's budget, has objected that industry influence may lead the foundation to encourage development of more profitable, but not necessarily safer, products. DeLauro plans to hold hearings on Reagan-Udall and other conflict of interest issues, a sign that FDA and pharmaceutical manufacturers will continue to face many challenges in the year ahead.

Jill Wechsler is BioPharm International's Washington editor, Chevy Chase, MD, 301.656.4634,


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