Biomedical loopholes

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On September 11, the nation was shocked into recognition of our vulnerability to possible terrorist incidents involving biological, chemical or nuclear materials. Yet, nearly four years later, there is a general consensus that America's arsenal of vaccines, diagnostic tools and other novel biomedical countermeasures to combat such threats remains seriously deficient.

To remedy this, Congress last year enacted BioShield I, a straightforward government research and procurement program that gives the federal government many of the tools needed to stimulate the research, development and production of novel biomedical countermeasures. Although BioShield I emphasizes the best features of government procurement and contracting in preparing the nation to meet biomedical threats, it has a few shortcomings that must be addressed. Instead of fixing those shortcomings, some members of Congress want to amend the law in a way that would jeopardize America's health-care system.

Several Senate proposals would create substantial opportunities for special interests to block timely access to affordable medicines, thus increasing health-care costs for American consumers. These proposals broadly define what is considered a "countermeasure"; create a "wild card" exclusivity patent extension; and allow for other creative patent extensions for already approved products.

First, by broadening the definition of "countermeasure," almost every drug in today's medicine cabinets would qualify as a countermeasure, and would be eligible for patent extensions. The definition would apply not only to novel countermeasures, but also to drugs currently on the market. Commonly prescribed drugs that treat secondary effects of a bioterrorist attack, such as migraines, anxiety and even erectile dysfunction, would be eligible for patent extensions after only minimal testing performed by the brand manufacturer, costing consumers tens of billions of dollars.

Second, the "wild card exclusivity" would allow for a two-year patent extension on any patent, at any time, even if that patent is completely unrelated to a countermeasure. For example, a brand company such as Pfizer could merely perform an inexpensive, small animal study to establish whether an everyday antibiotic is a viable treatment for anthrax. Regardless of the outcome and without producing a new product, Pfizer would be eligible for a patent extension for any one of its blockbuster products, such as Viagra.

In fact, most brand companies would use the wild card to extend the patent life of a blockbuster drug, which is usually protected by between five and ten patents. Wild cards could be applied to multiple patents covering the same product, which could extend the patent life far beyond what is acceptable under current law. By blocking competition at any time, the wild card would create uncertainty for the entire health-care system. Health insurers and government programs like Medicare would not be able to accurately predict their budgets and expenditures because they could not be certain that the generic would enter the market at the expected time.

Third, extending patents for drugs already approved also would significantly increase health-care costs. Under current law, innovation and access are balanced by providing only five years of the FDA's regulatory review period to be added to the patent's life. Under the Senate proposals, an existing product could be eligible for an additional decade of patent exclusivity and monopoly pricing by defining the regulatory review period to include when the Patent and Trademark Office issues the patent until the FDA approves the product. Providing such a generous patent extension is contrary to the goal of expediting research and development and does little to enhance our security.

Taken together, these proposals would inflate drug expenditures, impose major obstacles to the entry of generic drugs into the market, worsen the crisis for uninsured and older Americans and impose an inequitable burden on health-care providers. They also encourage brand pharmaceuticals to focus on legal maneuvers rather than on the discovery of innovative medicines. Relying on patent extensions instead of innovation will have a severe effect on the brand-drug development pipeline, perhaps extending the research and development dry spell years into the future.

The Generic Pharmaceutical Association is committed to working with Congress to find ways to improve BioShield and our nation's security. We strongly support BioShield I and the government procurement model it established, along with incentives that will enhance our nation's security during the war on terror.

Those incentives include product-liability protections, expanded tax incentives, fast-track FDA review, additional funding for biotech companies, and true research on priorities such as novel vaccines, antibiotics and drug products that fill a recognized security priority, as well as diagnostic agents and environmental detection systems. Each of these provisions advances the anti-terrorism goals of BioShield I without unduly burdening the health-care system.

Unfortunately, the proposals being advanced in Congress do not effectively meet those goals, and instead threaten to rescind the billions of dollars in savings that the generic industry has created for consumers. We must keep America safe from threats, and we can do so by maintaining the straightforward government procurement approach established in BioShield I. Thus, the legislative proposals that threaten the health and well-being of American consumers by placing life-saving prescription drugs out of their reach must be flatly rejected.

Kathleen Jaeger is President and CEO of the Generic Pharmaceutical Association.