Washington, D.C. (November 3, 2008) – Pharmaceutical Research and Manufacturers of America (PhRMA) Senior Vice President Ken Johnson issued the following statement today regarding federal preemption:

“Federal preemption, at its heart, is about protecting patients through nationally uniform and scientifically based warnings on prescription drug labels. Contrary to critics’ assertions, federal preemption is not about providing blanket immunity for America’s pharmaceutical research and biotechnology companies.

“Upholding 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 Food and Drug Administration (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.

“The FDA should be allowed to do its job to protect patients by overseeing drug warnings. Federal preemption can play a constructive role in achieving these national goals.

“One important point often remains silent in this debate: All medicines have some risks. FDA’s expert scientists must sometimes make tough choices when they approve a medicine that can help treat or save millions of patients, even as they recognize that some patients will experience serious side effects.

“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, personal injury lawyers and individual 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.

“Inadequate preemption can also harm patients by slowing or denying their access to potentially life-saving therapies. Look no further than the experience of domestic vaccine manufacturers driven from the market, in part, due to excessive liability exposure.

“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.

“PhRMA’s support of the Agency’s label oversight is consistent with five former FDA chief counsels, who maintained in a bipartisan letter: ‘If every state judge and jury could fashion their own labeling requirements for drugs and medical devices, there would be regulatory chaos for these two industries that are so vital to public health, and FDA’s ability to advance the public health by allocating scarce space in product labeling to the most important information would be seriously eroded.’

“FDA has acted aggressively, setting high and consistent standards for warning labels. While transparency is not an issue in the case that is before the Supreme Court, America’s pharmaceutical research and biotechnology companies should be accountable to a strong, well-resourced FDA. Any company that attempts to hide critical safety information from the FDA should be punished to the full extent of the law.

“The FDA has the power to punish companies with civil and criminal penalties if they fail to report required information to the Agency. The FDA takes this authority seriously and PhRMA fully supports accurate and timely reporting of side effects.

“But it is difficult to explain why the law should penalize companies that fully disclose all known risks to FDA, update those safety disclosures appropriately when new risks come to light, and work with the Agency to change the labels on medicines to accurately reflect new risks (or benefits).

“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 patient access to needed medicines, while adding no real benefit.”

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Contact:
Diedtra Henderson
Director, Communications & Public Affairs
202-835-3460