The FDA tobacco legislation introduced in Congress Thursday, which is supported by Philip Morris and the Campaign for Tobacco-Free Kids, contains an escape clause that would allow Philip Morris or any other tobacco company to appeal to Congress to overturn any major regulation that the company does not like. The legislation explicitly gives Congress the ability to review and, by majority vote, to overturn, within 60 days, any major tobacco rules promulgated by FDA, resulting in such rule having no force or effect.
Given the lobbying power of Big Tobacco in Congress, this essentially gives the companies the ability to block any substantial tobacco rules that would be expected to have significant financial consequences -- precisely those which might otherwise have public health benefit. The legislation makes it easier for Big Tobacco to obtain a Congressional override of an FDA rule by prescribing rules for the consideration of such override legislation that limit the ability of legislators who oppose such a measure to kill it (i.e., it prescribes rules that take away many of the procedural moves by which legislation can normally be killed).
The Rest of the Story
By keeping all major regulatory decisions within the oversight of Congress, the legislation politicizes what should be primarily scientific and public health issues. This provision in the legislation essentially represents an "escape clause" by which the tobacco companies could escape unfavorable regulation simply by mobilizing enough support within Congress to pass a joint resolution of rule disapproval. And the rules governing the procedure by which such a joint resolution is considered are geared towards making it more difficult than normal to kill such a measure.
The bill achieves this escape for Big Tobacco by making any major FDA rules subject to section 801 of Title 5 of the United States Code (Congressional review of agency rulemaking). However, the bill could presumably have exempted these regulations from Congressional review just as easily. In fact, the bill does exempt from Congressional review the advertising and youth access regulations that the Secretary of Health and Human Services would be forced to promulgate (the 1996 FDA regulations). However, the remainder of the rules that FDA is given the authority to promulgate are not exempted from the Title 5, Section 801 provisions.
Presumably, the simple inclusion in the legislation of a clause stating that ‘‘Section 801 of Title V of the United States Code does not apply to the regulations referred to in the Family Smoking Prevention and Tobacco Control Act" would allow FDA to regulate tobacco products without explicit Congressional review and would eliminate the short-circuited process by which Congress can override FDA rules under the current bill.
That the Campaign for Tobacco-Free Kids has stated that this legislation is "strong" and puts "protection of the public health first" is unfortunate, given their presumable knowledge that this "Philip Morris escape clause" was tucked away into the bill, apparently with the Campaign's approval.