PhRMA, BIO Release Drug Maker Communication Guidelines

The Pharmaceutical Research and Manufacturers of America and the Biotechnology Innovation Organization on Wednesday released guidelines for drug makers’ communications with other health care professionals about their products.

The groups, which represent the pharmaceutical and biotechnology industries, respectively, released nine principles aimed at improving between biopharmaceutical companies and other players in the health care industry. The organizations are calling on the agency to clarify what types of information biopharmaceutical companies can share in addition to approved labels.

Typically, biopharmaceutical companies share information with others in the industry through FDA-approved labels, but the companies often continue to gather information about the treatments after they are finalized, the trade groups say. Sharing that additional information can help professionals better understand treatment options and provide better care to patients, they say.

“Biopharmaceutical companies are uniquely positioned to help health care professionals achieve the best outcomes for patients, because companies can provide timely, accurate, and comprehensive information about both approved and unapproved uses of the medications they research, develop, and bring to patients,” the principles read.

The principles released today by PhRMA and BIO are centered around three areas: commitments to science-based communications, providing appropriate context about data and accurately representing data.

Insurers and drug companies agree that more dialogue between them could help at least in part address the high costs of specialty drugs. When companies introduce pricey specialty drugs to the market after insurers have set their rates for the year, it either falls to the insurer or the patient to pay for the drug.

But regulations around how much communication drug makers and insurance plans can have about treatments in the pipeline are unclear. There are currently “very limited safe harbors” to share information outside of FDA-approved labeling, said Jeff Francer, vice president of law at PhRMA. That extends to information gathered both before and after a drug is approved that isn’t included on a label.

Among the principles outlined, the trade groups call for biopharmaceutical companies to be able to share some information with insurance providers, pharmacy benefits managers and government health programs so that they’re better able to consider the potential costs of new medicines.

“We often hear that payers would like clinical trial information 12-18 months before a drug is approved, and we believe that FDA modernization in this area will help improve the efficiency of the health care market,” Francer said in an email. “Similarly, after approval, physicians may want to review real-world evidence such as data based on high quality studies of electronic medical records.”

When companies do share additional information outside of a pharmaceutical’s label, that information should be held to high standards, they say. The principles recommend that additional information be scientifically sound and include details about a study’s design, for example.

“Today, the wealth of information about medicines is more comprehensive and complex than ever before,” the principles say. “Scientific knowledge and new findings go far beyond data sets produced from clinical trials, often are outside the scope of the parameters established by Food and Drug Administration regulations, and often outdate the FDA-approved labeling.”