PHRMA

PhRMA Statement on Impact of Marketing on Drug Safety

Washington, D.C. (December 2, 2008) — Pharmaceutical Research and Manufacturers of America (PhRMA) Senior Vice President Ken Johnson issued the following statement today on drug safety:

“Unfortunately, the paper published today by the British Medical Journal suffers from a number of flawed assumptions, among the most glaring that Food and Drug Administration (FDA) deadlines for approving drugs have shifted the Agency’s focus away from patient safety.

“Since its original enactment, the Prescription Drug User Fee Act (PDUFA) has been a success for the FDA, taxpayers and, most importantly, patients. Simply put, the Act has helped to provide the FDA with the essential tools it needs to protect and promote the public health.

“While PDUFA does carry time frames for the completion of a review, the FDA can, and repeatedly has, returned to the sponsor with further questions about safety or efficacy that ultimately lengthen the review time.

“The fact remains that experts’ analysis – including a paper published in 2007 by the New England Journal of Medicine – showed no increase in the overall rate of safety recalls after the user-fee system was introduced.

“At the same time, the Agency has experienced a boost in Congressional appropriations and enhanced user fees paid by regulated industry and – importantly – additional regulatory authority to further bolster the safety and efficacy of products throughout their entire life cycle.

“Last fall, Congress passed the Food and Drug Administration Amendments Act of 2007 (FDAAA), which strengthened the FDA’s ability to protect and preserve public health.

“The measure significantly increased user fees to provide the FDA the resources necessary to improve and modernize its already strong drug safety system. The Agency will be able to enhance its use of epidemiology studies and large medical databases that contain a wealth of safety information. In addition, the Agency already is modernizing its Adverse Events Reporting System with the aim of better evaluating risk communication and risk management programs.

“The FDA has quickly embraced its enhanced postmarketing authorities. According to published reports, the Agency has required distribution of consumer medication guides, mandated postmarketing clinical trials and required Risk Evaluation and Mitigation Strategies for one-third of the drugs it has approved since acquiring the added authorities.

“Finally, it is erroneous to conclude that marketing plays a dominant influence on which medicines physicians prescribe. Marketing is only one of many factors that impact which remedies are prescribed to patients. For instance, payers use multiple tools – including health plan formularies, tiered co-pays and prior authorization – that strongly influence which medicines patients ultimately receive.

“According to a 2008 survey of 501 physicians, KRC Research found that peer-reviewed journal articles and information received from peers had more influence on physician prescribing decisions than industry marketing. What’s more, only 8 percent of physicians usually prescribed a brand-name medicine, while 41 percent of doctors surveyed usually prescribed generic drugs.

“That prescribing trend is reflected in the dominance of generic drugs in the U.S. The United States already has one of the highest rates of generic drug use in developed countries. According to IMS Health, a healthcare information company, nearly 7 of every 10 prescriptions in America are now filled with a generic drug.

“PhRMA has always supported patients receiving the medicines that are best for them, including both brand-name and generic drugs. Clearly, both innovative medicines and generic drugs play a valuable role in the treatment of millions of American patients. While innovative new medicines remain a very small part of total health spending, they play a very big role in improving health and quality of life. And without today’s innovative brand name drugs to legally copy, there would be no generic drug industry.”

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.

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