FDA Input On Coburn Drug Import Amendment Should Be Sought, Rep. Says

Congressional legislators should work with FDA on the final language of an amendment proposed by Rep. Coburn (R-Okla.) relaxing importation of drugs, Rep. Kaptur (D-Ohio) suggested during floor debate July 10.

Kaptur voiced safety concerns about the amendment to the agriculture appropriations bill that would prohibit FDA funds from being used to restrict the importation of drugs that are approved for use in the U.S. and manufactured at FDA-approved facilities in the U.S., Canada or Mexico.

The amendment covers all forms of agency enforcement, including the FDA practice of issuing letters to importers of drugs of unknown origin. The letters state that the importation is in violation of agency regulations and that the drugs could be seized.

Kaptur initially opposed the amendment, referring to FDA Commissioner Henney's recent assertion before Congress that FDA cannot assure that the products imported by citizens are equal in consistency and manufacture to U.S. products.

The Ohio Democrat asked if imported products could be identified as having been manufactured at an FDA-approved facility. "Maybe there is some way that FDA could indicate on the boxes that it is from an FDA-approved facility," Kaptur suggested.

Kaptur eventually withdrew her opposition to the amendment when co-sponsor Rep. Baldacci (D-Maine) suggested that FDA could work to tighten up language in the amendment during the conference committee. Coburn's amendment overwhelmingly passed the House on July 10 by a margin of 370-12.

An amendment also focusing on FDA enforcement letters for personal importation passed the House on June 28. The bill introduced by Rep. Gutknecht (R-Minn.) would place the burden of proof on the agency to show that importing a drug is illegal prior to issuing a letter to the importer (¹ (Also see "House Import Bill Shifts Burden To FDA; Rep. Dingell Opposes, Citing PDMA" - Pink Sheet, 10 Jul, 2000.)).

Another amendment to the appropriations bill introduced by Rep. Crowley (D-N.Y.) would prohibit FDA from using funds to enforce the ban against reimportation of American-made drugs back into the U.S. The amendment "takes away the authority of the FDA to prosecute any individual who reimports drugs that were made in this country," Crowley said.

Crowley added that his amendment may provide resources for FDA to pay greater attention to products imported from foreign manufacturers. "By taking FDA out of the business of harassing seniors," Crowley said, the agency might free up funds to make sure "what is being firsthand imported into America from abroad is safe."

The Crowley amendment passed the House by a vote of 363 to 12, with 59 members not voting.

Support for the two importation amendments preceded the July 11 House vote of 339-82 for passage of the appropriations bill (HR 4461).

Several amendments to the bill concerning FDA advisory committees, RU-486 and research cost and drug price disclosure were not included in the final appropriations.

Rep. Burton (R-Ind.) attempted to attach an amendment to the bill that would have prohibited FDA vaccine advisory committee members from being granted waivers to participate in committee deliberations if they had a conflict-of-interest. Burton argues that stock ownership in a firm with a competing product to the one being reviewed should be considered a conflict of interest (² (Also see "ACIP Chairman Ownership Of Merck Stock Challenged By Rep. Burton" - Pink Sheet, 19 Jun, 2000.)). The amendment lost 253-168.

Coburn also introduced an amendment targeting FDA's review of RU-486 (mifepristone) that would have prohibited the development or approval of any drug intended solely for the chemical inducement of abortion. FDA action on RU-486 is expected by Sept. 30 (³ (Also see "RU-486 Action Date Is Sept. 30; Allen Named Reproductive Division Director" - Pink Sheet, 12 Jun, 2000.)). The amendment was defeated 187-182.

An amendment proposed by Rep. Allen (D-Maine) would have required disclosure of the taxpayer-funded contribution to the total cost of research and development of a drug following approval.

Another amendment by Rep. Brown (D-Ohio) would have required public disclosure on a quarterly basis of the average price charged by a manufacturer for the most common dosage of a drug in countries that are members of the Organization for Economic Co-operation and Development. Both amendments were withdrawn.