CFC inhaler bill has support of House Commerce leadership in 1998, Rep. Kennedy says.

CFC INHALER BILL SUPPORT FROM HOUSE COMMERCE LEADERSHIP is expected in 1998, Rep. Patrick Kennedy (D-R.I.) declared during Nov. 9 House floor discussion of the FDA reform bill. Attempts to include a provision in the bill to rescind FDA's advance notice of proposed rulemaking on chlorofluorocarbon-containing metered-dose inhalers failed in the current session, but Commerce Committee Chairman James Bliley (R-Va.) and Ranking Minority Member John Dingell (D-Mich.) have "agreed to a bill that will address this issue in the upcoming year," Kennedy said.

Kennedy has a personal connection to the CFC issue: "I can tell the members, I have four different inhalers. I think there is only one of them that has a non-CFC component," he said. Sen. Edward Kennedy (D-Mass.) is understood to have supported inclusion of the CFC provision in the conference bill ("The Tan Sheet" Nov. 3, p. 9).

Glaxo is the most visible opponent of the FDA proposed rulemaking; Schering-Plough and 3M, which collaborate on the Proventil HFA CFC-free Rx inhaler, want the FDA process to move forward. As it now stands, the CFC legislation does not distinguish between Rx and OTC CFC metered-dose inhalers. Three OTC MDIs remain on the market: Whitehall-Robins' Primatene Mist, Bayer's Bronkaid Mist and Menley & James' Asthmahaler Mist.

On Nov. 8, Rep. Christopher Smith (R-N.J.) introduced a bill (HR 2968) requiring FDA to "take no further action on proposed regulation relating to the use of chlorofluorocarbons in metered-dose inhalers." Smith has two daughters with asthma.

The Smith bill directs that "any regulations under which [FDA] may remove essential use designations for the purpose of phasing out essential use allowances for drug products shall require [HHS] to certify to the Congress that alternatives to such inhalers are available that, for all populations of users of such inhalers, are comparable in terms of safety and effectiveness, therapeutic indications, dosage strength, cost and retail availability." HR 2968 further directs FDA to withdraw its March 6 announced notice of proposed rulemaking to "issue another proposal" following the tenth meeting of the parties to the Montreal Protocol in early 1998.

FDA's ANPR would ban CFC-containing MDIs once "three distinct" non-CFC products are available. FDA has indicated it expects to issue a proposed rule on elimination of CFC-containing MDIs by early 1998. The agency has emphasized there is no timetable for total elimination of CFC-containing MDIs.

Smith's measure is similar to legislation introduced by Sen. Tim Hutchinson (R-Ark.) and Rep. Mark Foley (R-Fla.) in October ("The Tan Sheet" Oct. 27, p. 12). HR 2968 co-sponsor and House Commerce Committee member Cliff Stearns (R-Fla.) withdrew a similar measure during a Commerce Committee markup of the House FDA reform bill in late October following assurances by Health Subcommittee Chairman Howard Bilirakis (R-Fla.) he would monitor FDA's rulemaking process for eliminating CFC-containing MDIs. In July, Stearns introduced a more limited bill, HR 2221, that would direct HHS to "take no further action to promulgate a final rule on the basis" of FDA's proposed rule.

House Majority Whip Tom DeLay (R-Tex.) has weighed in against a regulation to phase-out MDIs. He asserted Oct. 8 that the Environmental Protection Agency has "embarked on a crusade to ban inhalers used by asthmatic children because they contain chlorofluorocarbons." CFC-powered inhalers, he added, "are the cheapest and best way for inner city children to get relief from asthma."