Drug product labels could contain an array of comparative effectiveness data beyond well-controlled clinical trials, if Sens. Jack Reed, D-R.I., and Barbara Mikulski, D-Md., get their way.

Much of the current discussion on comparative effectiveness is concerned with ensuring that coverage policy and prescriber decisions are not locked in by CE data (see ¹ Also see "House Comparative Effectiveness Bill Includes “Physician Out” Clause" - Pink Sheet, 25 May, 2009.). But Reed and Mikulski are proposing a new way to put more muscle behind the data: product labeling.

The two senators introduced the "Informed Health Care Decision Making Act of 2009," S. 1142, on May 21. It directs HHS and FDA to "establish and periodically update methodological standards and criteria for the sources of evidence and the adequacy and degree of evidence that are appropriate for inclusion of comparative clinical effectiveness information in labeling and advertisements."

These standards "shall ensure that comparative clinical effectiveness information provides reliable and useful information that improves health care decision making, adheres to rigorous scientific standards, and is produced through a transparent process that includes consultation with stakeholders," including manufacturers of drugs and devices, clinicians, patients and consumer experts.

In a May 21 Senate floor speech, Reed said that once the standards are complete, "the legislation requires drug labels and print advertisements to include information on the clinical effectiveness of a product compared to other products approved for the same health condition for the same patient demographic sub-population or a disclosure that there is no such information if another product has not been approved for the same use."

The legislation raises some provocative questions. The FDA Amendments Act already gave the agency more authority to dictate the contents of labeling regarding safety, should negotiations break down with the sponsor. The agency used that authority to add safety data to labels on erythropoiesis-stimulating agents (² Also see "FDA Draws Upon New Authority To Mandate Elements OF ESA Labeling" - Pink Sheet, 4 August, 2008., p. 3). And of course, manufacturers sometimes seek to add data in addition to the trials conducted for marketing approval. But the prospect that manufacturers might be directed to include data - particularly efficacy data disadvantaging their products versus other cited products - could take labeling in a distinctly new direction.

Reed also offered a perspective likely to irk manufacturers already concerned about the impact of CE: the "potential of such a disclosure should be a powerful incentive for manufacturers to fund comparative research," he said.

The Rhode Island senator is not known for spearheading major health care legislation, but back in 2002, he urged FDA to hold a meeting on the agency's commercial speech policy (³ 'The Pink Sheet,' Aug. 26, 2002, In Brief). Both he and Mikulski serve on the Senate Health, Education, Labor and Pensions Committee.

A Standardized "Drug Facts" Box

The bill also includes provisions bringing renewed attention to the idea of a drug facts box to aid consumers and others. It would direct FDA to "determine whether standardized, quantitative summaries of the benefits and risks of drugs in a tabular or drug facts box format, or any alternative format, in the labeling and print advertising of such drugs would improve health care decision making by clinicians, patients and consumers."

FDA would have one year to report on its findings. If it determined that such a summary would benefit Rx decision-making, FDA would have another year to issue rules on a drug facts box.

Reed said researchers at Dartmouth University "have documented that replacing the current narrative information contained in drug advertisements with simplified, factual information will enable patients to play an active role in health care decision-making." He compared this with nutritional information found on packaged food.

During confirmation hearings for incoming FDA Commissioner Margaret Hamburg, Mikulski asked how Hamburg would guide Congress in terms of legislating the presentation of efficacy information. The Maryland senator also cited the Dartmouth study; Hamburg noted she was not familiar with it (⁴ Also see "Commissioner Nominee Hamburg Questioned On FDA’s Role In Health Reform" - Pink Sheet, 11 May, 2009., p. 3).

Members of the FDA Risk Communication Advisory Committee recently endorsed something the agency itself has been considering: a single document similar to a nutritional facts box in lieu of numerous documents that patients receive at the pharmacy (⁵ Also see "FDA Poised To Overhaul Distribution Of Consumer Medical Information" - Pink Sheet, 9 March, 2009., p. 35).

- Gregory Twachtman (g.twachtman@elsevier.com)

Opening Product Labeling To Broader CE Data Is Proposed In Senate Bill

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