Chairman Henry Waxman (D-California) is very close to achieving one of his objectives stretching back more than a decade: granting explicit authority for the Food & Drug Administration to regulate the marketing and development of tobacco products. The Family Smoking Prevention and Tobacco Control Act (HR 1256) passed the House on April 2 by a commanding 298-112 vote and was cruising toward Senate passage this week.
But then Sen. Byron Dorgan (D-ND) hauled out one of his long-term favorite projects (drug reimportation) and created a nasty hurdle in the final stretch of Waxman’s long journey. Dorgan (D-ND) proposed the “Pharmaceutical Market Access and Drug Safety Act of 2009” on June 2 to be introduced as an amendment to the anti-smoking bill. Dorgan has five of long-time allies on the issue: Olympia Snowe (R-ME), John McCain (R-AZ), Debbie Stabenow (D-MI), Bernie Sanders (I-VT) and Amy Klobuchar (D-MN).
There is an interesting irony for Waxman as Dorgan tries to ride the success of the smoking bill. Waxman has never been a proponent of permitting drugs from lower cost markets to be imported to the U.S. as a cost control measure. That approach has been treated by Waxman and other prominent Democratic leaders in the health area as a distraction from more direct ways to address drug prices and a threat to FDA’s ability to protect quality manufacturing for pharmaceuticals.
If Dorgan can link drug reimportation onto the tobacco bill, Waxman may be faced with having to accept a provision he has fought for years if he wants to move forward with one of his top public health priorities.
Experience says that Dorgan will fail to attach reimportation in any meaningful way. Advocates for a strong FDA are watching the Dorgan amendment effort with worry and distaste. Adding tobacco authority and working to improve food control are big projects by themselves. FDA doesn't need to try to undertake the complicated system for assuring safe imports of drugs marketed in Canada or elsewhere. Congress has foiled the reimportation attempts many times in the past or added provisions that made in difficult or impossible to implement. But like Waxman’s tobacco crusade, reimportation seems to be an issue that won’t go away.
The environment around the reimportation debate is changing also. When the proposal first came up, opponents were able to raise the convincing threat of unsafe or poorly manufactured products from outside the US slipping into the domestic drug supply if reimportation were passed.
However, with many manufacturers outsourcing production of active ingredients to a wide variety of low-cost manufacturing locales, they are effectively eroding their own defense-of-quality argument. Domestic suppliers (brand and generic) have had enough well-publicized problems assuring the quality of their products with components from overseas to create a more favorable environment for reimportation. It is one of those Congressional pet projects which might linger around long enough to find the right time for enactment.
Kind of like FDA regulation of tobacco.