New Congress, New Challenges in the Year Ahead - Pharmaceutical Technology

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New Congress, New Challenges in the Year Ahead
Reauthorization of PDUFA will focus attention on drug safety, product pricing, and a host of regulatory issues.

Pharmaceutical Technology

In December 2006, FDA held a public hearing on the feasibility of requiring drug manufacturers to submit regulatory documents electronically. Such a mandate would apply initially to applications to conduct clinical trials and to gain approval for new drugs, biologics, and generic drugs. Eventually it would extend to adverse event reports, postapproval amendments, and other applications. FDA acknowledges that it would need to improve its own capability for collecting information electronically but anticipates that e-data systems would facilitate access to important drug information for both internal and external assessment.

These efforts build on FDA's requirement that pharmaceutical companies file drug-labeling information electronically, beginning with newly approved drugs and those filing efficacy supplements. The rule also revises the content and format of the package insert to provide the most important information about prescription drugs up front where it can be better understood and more easily accessed by health professionals as well as patients. These data are establishing an electronic prescribing information database, operated by the National Library of Medicine and readily available to the health community.

Spurring innovation

A main fear of FDA officials and industry executives is that mandates for more safety data and curbs on uses of approved medicines could slow drug development and approval. The decline in innovative new therapies coming to market prompted FDA to launch its Critical Path initiative two years ago and to release its Critical Path Opportunities List in early 2006. Since then, the agency has been encouraging the formation of consortia and cooperative projects that can yield new tools for evaluating test therapies, for streamlining clinical trials, and for modernizing manufacturing methods, equipment and facilities.

These activities support the development of personalized medicine based on pharmacogenomics data able to identify those individuals most likely to respond to a medicine or to experience serious side effects. Although this represents a major departure from the blockbuster-drug development model, targeted therapy has been championed by FDA and federal health officials, and manufacturers are recognizing that new drugs for broad patient populations now may be hard to identify.

Pharmaceutical companies are joining the shift to personalized medicine by supporting new consortia and other efforts to identify and validate new biomarkers and develop new diagnostics and screening tests to identify certain enzymes and receptors linked to response. FDA is encouraging broader use of pharmacogenomics data by offering manufacturers early informal advice about how to analyze and submit genomic data that facilitate regulatory review. Scientists from FDA, industry, and academia seek to develop standards and best practices for submitting and validating such information and gene-expression measurements in microarrays.

Developing countermeasures

The national campaign to build defenses against terrorist events and emerging health threats is spurring innovation in vaccines and new countermeasures for anthrax, plague, radiation emergencies, and dangerous viruses and infectious diseases. FDA plays a central role in ensuring the quality and safety of these new therapies, as well as vaccines and treatments for seasonal and pandemic influenza. Congress recently approved legislation to expand funding for private research on new treatments, which should spur new research efforts. OIG investigators are examining FDA's progress in assessing and inspecting vaccine-manufacturing processes; in developing and assessing new vaccine-production technologies; and in monitoring the safety and effectiveness of pandemic vaccines through improved information and reporting systems.

More on Medicare

Campaigning Democrats called for lower drug prices and improved access to needed treatments and now are weighing options to deliver on these promises. A top priority for new House Speaker Nancy Pelosi (D-CA) is to repeal Medicare's "noninterference" clause so that the government can negotiate for lower drug prices directly with pharmaceutical companies instead of leaving that task to private prescription-drug plans.

Such a change will not be easy. Democrats could push through a straight repeal measure, but that would not necessarily alter the program under a Republican administration that believes private drug plans can negotiate prices better than bureaucrats. An alternative is to establish a separate government-run drug plan that would compete with all the private insurers, but this, too, would be difficult to implement. Industry fears that a move by the federal government to negotiate drug prices for all Medicare beneficiaries will lead to a national formulary with set prices for the government program and ultimately the broader market. Reformers like to point to the low drug prices enjoyed by the Veterans Administration (VA), but usually fail to note that the VA has a smaller formulary than most Medicare drug plans and serves a relatively small patient population. Even so, repeal was a favorite Democratic campaign slogan and one the new leaders will try hard to fulfill as they gear up for the bigger presidential election campaign in two years.

Pharmaceutical and biotechnology companies may be more enthusiastic about Pelosi's promise to expand federal support for embryonic stem-cell research. Increased funding for biomedical research, however, won't do much good if added regulation and price controls dry up financial investment in the biotechnology industry, points out Greenwood of BIO. "We need to persuade the new leadership that when they're making speeches on stem-cell research, they have to make sure that biotechnology companies will be there to develop the promised new cures," Greenwood comments. "We need to protect the biotechnology goose laying the golden eggs."

Jill Wechsler is Pharmaceutical Technology's Washington editor, 7715 Rocton Ave., Chevy Chase, MD 20815, tel. 301.656.4634,


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