House Passes FDA Appropriations Bill With Drug Importation Provision

Last week, the U.S. House of Representatives passed H.R. 3161, the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for Fiscal Year 2008.  The bill, which, among other things, funds FDA’s discretionary spending for the upcoming fiscal year, “fully funds the [President’s request] for the FDA and provides targeted increases of $55 million,” according to the House report accompanying the bill.  These “targeted increases” are with respect to food safety activities, speeding up generic drug application reviews (with a $5 million increase to FDA’s Office of Generic Drugs), post-market drug safety reviews, and review of direct-to-consumer drug ads. 

The bill also includes a controversial provision that would allow the importation of certain prescription drugs into the United States.  Specifically, Section 726 of H.R. 3161 states:

None of the funds appropriated or otherwise made available by this Act for the [FDA] may be used under section 801 of the [FDC Act] to prevent an individual not in the business of importing a prescription drug within the meaning of section 801(g) of such Act, wholesalers, or pharmacists from importing a prescription drug (as defined in section 804(a)(3) of such Act) which complies with sections 501 [(adulteration)], 502 [(misbranding)], and 505 [(new drug approval)] of [the FDC Act].

Representative Jack Kingston (R-GA), who was unsuccessful in his attempt to get an amendment passed to strike the importation provision, commented in the House Report on H.R. 3161 that “[i]f this provision is going to remain in the bill, then there should be funding to ensure the safety and efficacy of those imported drugs.”

FDA explained its current importation policy in a February 2003 letter issued in response to inquiries about the liability of various parties involved in importing prescription drugs from Canada.  FDA’s letter states:

The reason that Canadian or other foreign versions of U.S.-approved drugs are generally considered unapproved in the U.S. is that FDA approvals are manufacturer-specific, product-specific, and include many requirements relating to the product, such as manufacturing location, formulation, source and specifications of active ingredients, processing methods, manufacturing controls, container/closure system, and appearance.  21 C.F.R. § 314.50.  Frequently, drugs sold outside of the U.S. are not manufactured by a firm that has FDA approval for that drug.  Moreover, even if the manufacturer has FDA approval for a drug, the version produced for foreign markets usually does not meet all of the requirements of the U.S. approval, and thus is considered to be unapproved.  21 U.S.C. § 355.

The U.S. Senate Appropriations Committee, which passed its version of the appropriations bill, S. 1859, on July 19, 2007, does not include a similar importation provision.  The Senate report accompanying the bill, however, includes an amendment, sponsored by Senator Byron Dorgan (D-ND) that would require FDA to:

issue a report, using available data sources, within 120 days of enactment of this act, that outlines the location of the manufacturer of all drugs approved since January 1, 2000; the location of the manufacturer of the active ingredient in each of those drugs, only as submitted in the original application; the extent to which drugs manufactured overseas and commercially distributed in the United States are subject to different regulation than drugs manufactured and distributed in the United States; and the procedures taken when a manufacturer changes the procurement of active ingredients for their drugs.  The Committee further directs that the FDA present this information in such as way as to not violate any commercial confidential, trade secret, or proprietary information.

Sen. Dorgan, who was unsuccessful in his attempt to add a provision to the FDA Revitalization Act (S. 1082) permitting prescription drug importation, issued a press release stating that the “action comes on the heels of an all out attack by the big drug makers on legislation sponsored by Dorgan and Senator Olympia Snowe to allow the importation of lower priced prescription drugs from other countries.  The drug makers argue prescription medicines imported from other countries are inherently dangerous and that there is no way to guarantee their safety.”  According to Sen. Dorgan, “I am not claiming that drugs made overseas are dangerous, but if that’s the argument drug manufacturers are going to make to block importation of lower priced medicines, then Americans have a right to know the origin of prescription medicines the drug companies are already selling here.”

The National Association of Manufacturers and the National Association of Chain Drug Stores, among other organizations, have voiced opposition to the inclusion of a provision permitting prescription drug importation in appropriations bills (and other legislation).  In addition, the White House has objected to the importation provision in H.R. 3161.  Specifically, the Office of Management and Budget (“OMB”) stated the following in a July 31, 2007 Statement of Administrative Policy:

The Administration strongly opposes the prescription drug importation provision, which does not include any protections to ensure that imported drugs are safe and effective and which will have a negative effect on incentives for beneficial innovation. In 2004, a Department of Health and Human Services Task Force found that there are significant safety and economic issues that must be addressed with respect to prescription drug re-importation. While the provision theoretically limits importation to only FDA-approved prescription drugs, it would be impossible for FDA to verify at the border that they are not counterfeit.

The White House has previously threatened to veto certain legislation permitting importation.  For example, OMB stated in a May 1, 2007 Statement of Administrative Policy with respect to Senate efforts to include an importation provision in S. 1082 that:

The Administration would also strongly oppose any provision that might be added on the Senate Floor regarding the importation of prescription drugs that does not address the serious safety concerns identified in the December 2004 Department of Health and Human Services Task Force Report on Prescription Drug Importation.  The Administration believes that allowing importation of drugs outside the current safety system established by the FDA without addressing these serious safety concerns would threaten public health and result in unsafe, unapproved, and counterfeit drugs being imported into the United States.  As a result, if any such importation provision were included in the final version of the bill presented to the President, the President’s senior advisors would recommend that he veto the bill.

Although drug importation legislation appears to be off the table as an item for consideration in pending omnibus FDA reform legislation, it appears that the House and Senate are headed for a showdown over the issue as a part of FDA appropriations legislation.