Physicians Deserve Timely Authoritative Risk Information For Medicines

A Washington Post article today inaccurately describes the Food and Drug Administration’s (FDA) proposed guidance on distributing peer-reviewed scientific and medical information to healthcare professionals.

The FDA guidance recommends logical practices for biopharmaceutical companies to disseminate new risk information to healthcare professionals and rightly recognizes that, “the safety profile of a drug evolves throughout its lifecycle as the extent of exposure to the product increases,” and that “it can be helpful for health care practitioners to receive significant new risk information about an approved product in a timely manner.”

PhRMA and our member companies strongly agree with FDA that healthcare professionals deserve authoritative risk information in a timely manner.

Rather than carefully examining how the FDA’s guidance can help physicians and patients, the article makes unfounded claims that sharing new, scientifically-accurate information will undermine the FDA’s authority and put patients at risk.

In fact, the standards set forth in the FDA proposal would promote greater patient safety and care by creating a more open exchange of critical treatment information.

PhRMA believes that FDA’s regulation of medical communications – especially important safety information – should ensure that healthcare professionals benefit from scientifically accurate, data-driven information from all sources, including the companies that research and develop new medicines.

The FDA plays a critical role in evaluating the safety and efficacy of new medicines. At the same time, we also must recognize the critical need for healthcare professionals to receive the most current, accurate and comprehensive scientific information about both the benefits and risks of medicines, especially when patients are being treated with such medicines. Today, this information can exist in many forms, including peer reviewed articles, outside of the FDA’s review process and approved medicine labels.

Any appropriate regulation by FDA in this area requires careful balancing of these interests.

A free flow of scientifically accurate information can benefit patients through the education of their healthcare professionals and others involved in care decisions, such as formulary and P&T committees.

We support the FDA’s efforts to provide clear direction regarding best practices for disseminating peer-reviewed articles and information to physicians and other professionals. Our health care system is best served by an open dialogue among all parties to ensure physicians have the most accurate and complete information to meet their patients’ needs.