Rx ADVERTISING: FDA Backs Off On Direct-Mail Promotions
The Food and Drug Administration's attempt to crack down on pharmacy benefit management (PBM) companies that target consumers for direct-mail pharmaceutical promotions based on individual prescription patterns "has been sidetracked," the Washington Post reports. A "fierce lobbying campaign from the pharmaceutical industry and questions from key lawmakers" has at least temporarily halted the FDA's attempt to rein in what "both sides agree" is "a key element of managed pharmacy care" -- "letters sent out by [PBMs] ... urging doctors and patients to switch drugs." In January, the FDA announced that the PBM mailings might "violate agency prohibitions against promoting drugs without providing adequate information about their use." The agency said it was especially suspicious because the PBM efforts often "appear[ed] to echo" pharmaceutical marketing efforts. In some cases, the PBMs were owned outright by the company whose drugs were being promoted. Eli Lilly & Co., Merck & Co., and SmithKline Beecham PLC own PCS Health Systems, Merck-Medco Managed Care and Diversified Pharmaceutical Services, respectively.
On Second Thought
The FDA had proposed holding pharmaceutical companies "responsible for [PBM's] letters or other communications that violate federal regulations -- if the agency can show that content was influenced by the manufacturers." But under high-level pressure after the "Pharmaceutical Care Management Association arranged nearly 50 meetings in Congress," the FDA "quietly announced ... that it would put off issuing a final policy, start the entire process over and issue a new proposal" by the fall. The Post reports that "[i]ndustry officials" argued that the proposed FDA restrictions "could gut managed-care efforts to improve care while containing the rising costs of drugs" (O'Harrow, 7/17).