PHRMA

PhRMA Statement on Federal Preemption

Washington, D.C. (June 11, 2008) — Pharmaceutical Research and Manufacturers of America (PhRMA) Senior Vice President Ken Johnson issued the following statement today regarding federal preemption:

“Federal preemption is not about providing blanket immunity for America’s pharmaceutical research companies. It is about allowing the Food and Drug Administration (FDA) to do its job to protect patients by overseeing drug warnings.

“Federal preemption can play a constructive role in achieving national goals. “For 70 years, Congress has charged the FDA with ensuring that medicines are adequately labeled to warn about potential side effects. Patients and healthcare providers should be concerned that, without adequate preemption, lawyers and states could require information that conflicts with FDA’s expert judgment. These inconsistencies may be, at best, confusing, or at worst, life-threatening, because patients and providers could be scared away from needed medicines.

“Indeed, patients are best protected by a single, strong, uniform regulatory authority that is the sole arbiter of the benefits and risks of medicines. That is why Congress empowered the FDA to approve how that information is conveyed on the medicine’s label.

“The U.S. regulatory system for prescription drugs already is one of the world’s most rigorous. Regrettably, while Congress has increased the FDA’s regulatory responsibilities dramatically, it has not sufficiently increased the agency’s appropriated funds. This disparity has been highlighted by the FDA’s own Science Board.

“The health and safety of the American public rests on a strong, well-funded FDA. We applaud the efforts of U.S. Senators Herb Kohl and Robert C. Byrd to bolster Congressional appropriations to the agency and ask their Congressional colleagues to significantly increase appropriated resources to help the FDA realistically fulfill its regulatory obligations.

“PhRMA wholeheartedly supports the Administration’s attempt to boost FDA funding by $275 million – over and above the $2.4 billion previously included in the President’s budget. Some $100 million of those extra dollars will be devoted to strengthening FDA’s ability to help assure the safety and effectiveness of medical products from their development to post-approval. The agency also stands to receive additional appropriated dollars to track side effects linked to medical products more aggressively.

“However, such efforts to strengthen the FDA should not be diluted by substituting the opinions of lawyers and juries for the expert judgment of FDA’s scientists and doctors. Allowing prescription medicine labels to become clogged with inconsistent warnings would confuse physicians and frighten away patients from taking life-saving and life-enhancing medicines. That would harm, not help, public health.

“Contrary to critics’ allegations, federal preemption will not deny patients their day in court. State judges and juries may still levy damages against manufacturers that fail to comply with FDA standards. But those state judges and juries should not be permitted to interfere with an important public health goal: Uniform, science-based risk communication.

“America’s patients benefit from a regulatory system that is one of the world’s best at balancing safety and access. Permitting state law actions to undermine this inherently federal function could serve to impede access to patients, while adding no real benefit.”

The Pharmaceutical Research and Manufacturers of America (PhRMA) represents the country’s leading pharmaceutical research and biotechnology companies, which are devoted to inventing medicines that allow patients to live longer, healthier, and more productive lives. PhRMA companies are leading the way in the search for new cures. PhRMA members alone invested an estimated $44.5 billion in 2007 in discovering and developing new medicines. Industry-wide research and investment reached a record $58.8 billion in 2007.

PhRMA Internet Address: www.phrma.org

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