Sen. Kohl Joins Ranks Of DTC Legislation Sponsors
This article was originally published in The Pink Sheet Daily
Executive Summary
The Wisconsin Democrat's forthcoming bill would follow the "FDA Safety Act" and the "Pharmaceutical Advertising & Prudent Purchasing Act," both currently pending.
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Sen. Herb Kohl (D-Wisc.) will introduce legislation to address the shortcomings of direct-to-consumer advertising as a public education tool. DTC ads do not provide the public with sufficient information to make safe and informed choices, the senator said Sept. 29 during a Committee on Aging hearing on the impact of advertising on seniors' health and health costs. Kohl advocated for "more unbiased research, perhaps with the NIH, that will compare new and old drugs to help doctors and patients determine which is the best, most cost-effective medicine for them." "It shouldn't be left solely to the drug industry to educate patients and doctors about new medicines," he added. "We also need to give doctors time to fully understand the benefits and risks of a new drug once it reaches the market," the ranking member said. "Ads for newly approved drugs hit the airwaves immediately, sending patients to their doctors to request what they have seen." "We should consider a moratorium on advertising for newly approved drugs to provide doctors enough time to fully understand their effects," he proposed. In addition, "providing stronger enforcement tools to the FDA will help prevent unnecessary utilization costs and potentially harmful outcomes to patients." "I am working on legislation to address some of these issues," Sen. Kohl said. The legislation likely will be introduced in the next month or two and referred to the Health, Education, Labor and Pensions Committee. Other legislation pending in the Senate aimed at regulating DTC ads includes the "FDA Safety Act" (S 930), which would require all promotional materials for new drugs to be pre-cleared by FDA, and the "Pharmaceutical Advertising & Prudent Purchasing Act" (S 1128), which would deduct Rx advertising costs from government purchases of drugs (1 (Also see "DTC Advertising Bill Would Mandate Deeper Rx Discounts For Medicaid" - Pink Sheet, 26 May, 2005.)). "According to the figures from the Congressional Budget Office, we could get close to half of the savings that are needed for the Medicaid budget target just if we…took advertising expenses out of the cost of government health programs like Medicaid," Sen. Ron Wyden (D-Ore.) said at the hearing. Additionally, Senate Majority Leader Bill Frist (R-Tenn.) has called upon pharma to voluntarily implement a two-year moratorium on DTC for new drugs (2 (Also see "Sen. Frist's Diagnosis On DTC: GAO Report, Two-Year Moratorium For New Drugs" - Pink Sheet, 1 Jul, 2005.)). FDA will collect additional insight into DTC advertising at a two-day public hearing Nov. 1-2 (3 (Also see "FDA To Convene Two-Day Meeting On DTC Advertising" - Pink Sheet, 12 Sep, 2005.)). CDER Office of Medical Policy Deputy Director Rachel Behrman addressed the upcoming meeting during the committee hearing. "One question we are bringing to this public meeting…in November is, given that it's to a consumer audience, 'What's the bare minimum of contextual information about the disease, about the condition, about other therapies that must be provided, so that it is truthful and not misleading?'" - Brian Marson |