The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 ("MMA") provides that the Secretary of HHS shall promulgate regulations permitting pharmacists and wholesalers to import prescription drugs from Canada into the United States. It also provides that the Secretary may grant to individuals, by regulation, or on a case by-case basis, a waiver of the prohibition of importation of a prescription drug or device or class of prescription drugs or devices, under such conditions as the Secretary determines to be appropriate. Montgomery County, Maryland, hot in pursuit of the option to import prescription drugs from Canada sought a waiver from Mr. Leavitt and was denied. In Montgomery County, Maryland v. Mike Leavitt, et al., Civil Action No. AW-06-477 (D.MD 2006) Montgomery County sought review and a mandatory injunction under the Administrative Procedures Act to compel Mr. Leavit to grant it a waiver. Late last month, the Court dismissed the County's action without a hearing.
Section 384(l) of the MMA requires certification by the Secretary of Health and Human Services that implementation will pose no additional risk to the public's health and safety and will result in significant reduction in the cost of covered products to the American consumer before the waiver provisions can take effect. Mr. Leavitt, to date, has not so certified. The Secretary, in refusing to issue certification, relies at least in part on the perception by the FDA that such an importation program would violate the Federal Food, Drug and Cosmetic Act, 21 U.S.C. Section 301 ("FDCA"), which requires drugs to be approved by the FDA prior to importation into the United States. The FDCA also provides that even if a manufacturer obtains approval for a drug, the version that the manufacturer produces for a foreign market is an unapproved drug if it has not been manufactured according to FDA stipulations, including those regarding packaging, dosage and labeling requirements. See Section 331(a), (d) and 21 C.F.R. 314.50. Also, anyone other than the original manufacturer who re-imports or causes the re-importation of FDA-approved drugs originally manufactured in the United States violates the FDCA. Section 381(d)(1), 331(t).
The court, noting that Mr. Leavitt's actions are entirely discretionary in the matter and that there would be no standards by which to measure the reasonableness of his exercise of discretion, refused the County's request for a mandatory injunction. In otherwords, the MMA permits and authorizes importation from Canada, but the importation will not be certified by the Secretary because the exercise of his discretion would violate the FDCA. Got it? Catch 22. Brilliant in design and application.
Comments