Thursday, October 20, 2011

Vitter Amendment (#769, as Modified) on FDA Reimportation

Senator Vitter has offered an amendment (#769) regarding prescription drug reimportation.  The amendment is pending, and a vote on the amendment may occur later this evening.  
  • The amendment would prohibit the use of funds for the Food and Drug Administration “to prevent an individual…from importing a prescription drug from Canada that complies with the Federal Food, Drug, and Cosmetic Act.”
  • The amendment further provides that drugs reimported may not be controlled substances or a biological products.
  • The amendment prohibits the use of funds for the Food and Drug Administration “to change the practices and policies…in effect on October 1, 2011, with respect to the reimportation of prescription drugs into the United States…with respect to such importation by individuals from countries other than Canada.”
  • The Senate last considered prescription drug reimportation in 2009, during debate on the health care bill (H.R. 3590, 111th Congress).  At that time, a Dorgan amendment (#2793) regarding remportation failed on a 51-48 vote (60 votes were required for adoption).  Press reports from that time indicated that some Senate Democrats considered the amendment a “threat” because it would jeopardize the “rock-solid deal” Democrats made with the pharmaceutical industry.
  • In May 2007, the Senate considered reimportation in the context of FDA reauthorization (S. 1082, 110th Congress).  At that time, a Dorgan amendment (#990) regarding reimportation was adopted by unanimous consent, following a 63-28 vote to invoke cloture.  However, according to the Congressional Research Service, the Dorgan amendment was “effectively negated” by a second-degree Cochran amendment (#1010), which required the Secretary of HHS to certify that reimportation would 1) pose no additional public health risk and 2) “result in a significant reduction of cost” to consumers.  That second-degree Cochran amendment was adopted on a 49-40 vote.
  • In May 2006, the Senate considered a reimportation amendment as part of the Homeland Security appropriations measure (H.R. 5441, 109th Congress).  The Vitter amendment (#4548), which blocked Customs and Border Protection from enforcing prescription drug reimportation from Canada, passed on a 68-32 vote, and was ultimately included as Section 535 of the appropriations conference report (P.L. 109-295).
  • This amendment is a limitation-of-funds provision.  Under Rule XVI, any additional provisions would not be germane to the underlying appropriations measure.  In other words, this amendment differs from stand-alone reimportation legislation (S. 319) introduced earlier this year.
  • The amendment would only prohibit FDA from enforcing reimportation regulations regarding drugs from Canada, and not pharmaceuticals reimported from other countries.
  • Supporters of reimportation argue that the measure would result in drug price reductions for American seniors, while opponents of reimportation argue that other countries’ pharmaceutical supplies would raise concerns about drug safety.

UPDATE: Three additional points of note regarding this amendment:

  • A vote on the Vitter amendment (as modified) on reimportation is now scheduled for the noon vote series, and will be subject to a 60-vote threshold for adoption.
  • In my background section above, I neglected to mention a second reimportation vote in the 111th Congress, one that was NOT tied into the broader health care debate.  In July 2009, a Vitter reimportation amendment (#1467) was agreed to on a 55-36 vote.
  • Finally, the amendment omits language included in several prior reimportation amendments – including that in Section 535 of P.L. 109-295 – that prohibited reimportation enforcement “only to individuals transporting on their person a personal use quantity” of pharmaceuticals, “not to exceed a 90-day supply.”  Because the Vitter amendment excludes the preceding language, it has the effect of also permitting reimportation via mail order and Internet pharmacies based in Canada – which is a change from several of the prior reimportation amendments that were adopted.