FDA scrutinizes PBMs' restrictions of drugs
Apparently there has been enough complaint by consumers about managed care's formulary restrictions and drug switching to arouse the U.S. Food and Drug Administration's (FDA) regulatory juices. The agency is proposing new rules to regulate pharmacy benefit management (PBMs) companies owned by pharmaceutical manufacturers.
The drug makers have until April 6 to comment on the proposed regulations; a new policy is expected later this year. About 115 million Americans are covered by PBMs.
PBMs, especially those owned by drug makers, have come under fire recently from consumer groups that claim the PBMs are switching patients to less expensive and less effective drugs to save money, or are switching patients to drugs manufactured by their parent companies.
The FDA, which has been monitoring this activity, says it has found problems with PBMs giving doctors false or biased information about drugs, sometimes making claims about efficacy that have not been approved by the FDA.
The new rules would require PBMs to submit promotional material to FDA for approval, much as drug manufacturers submit advertising material for approval now.
PBMs not owned by drug makers, but which have financial agreements with drug makers - a large percentage of all PBMs - may be required to adhere to the new rules as well.
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