Food and Drug Administration (FDA),U.S. Department of Health
The Food and Drug Administration today published a draft
guidance concerning promotional practices by pharmacy benefits
management companies (PBMs) and similar enterprises that are
owned or influenced by the sponsors of medical products.
Today's Federal Register carries a notice of the availability
of this draft guidance. The draft guidance describes FDA's
regulatory authority under the Federal Food, Drug and Cosmetic
Act over the promotional practices of this growing number of
PBM/medical product sponsor ventures.
"Today's proposal will help FDA keep pace with changes in the
promotion of medical products, said FDA Lead Deputy
Commissioner Michael Friedman. "While PBMs can be useful tools
for managing health care costs, FDA wants to ensure that
patients are not put at risk by improper marketing practices."
Medical product "switching" -- the substitution of one therapy
for another as result of financial incentives -- is one area of
concern regarding the growing trend toward drug and device
sponsor ownership or partnerships with PBMs and other health
care organizations. This practice could have serious health
implications for patients -- particularly for those dependent
on chronic therapy -- if medical decisions are influenced by
incorrect or misleading information.
Concerns about drug switching and other potentially harmful
promotional practices have come to light as a result of several
in-depth analyses of PBM involvement in medical decision
making, conducted by FDA, the Health Care Finance
Administration, and the Department of Health and Human
Service's Office of Inspector General. In addition, FDA has
sponsored a major public hearing and issued a notice in the
Federal Register seeking public comment on this issue.
After thoroughly reviewing these analyses and comments, the
agency has developed this draft guidance that includes the
following factors for determining whether a medical product
sponsor can be held responsible for the promotional activities
of a nonsubsidiary PBM that violate the Federal Food, Drug and
The Relationship of the Sponsor and the PBM/ The nature and
extent of a PBM's ties to a medical product sponsor.
Sponsor Control or Influence over the Information Content and
Provided by PBMs/ The role medical product sponsors may play in
assisting PBMs in promotional activity.
FDA is seeking public comment on this proposal over the next 90
days and these comments will be considered in the development
of a final guidance. Written comments may be submitted to:
Dockets Management Branch (HFA-305)
Food and Drug Administration 12420 Parklawn Drive, Rm. 1-23
Rockville, MD 20857
ATTENTION TV BROADCASTERS: Please use open caption for the
Distributed by AEGIS - http://www.aegis.com