Capital Capsules for June 18, 2001
Recent cases involving counterfeit injectables and reports from Congressional investigators that U.S. mail facilities are being overwhelmed by prescription drug shipments from overseas make it increasingly likely that the Bush Administration won't resurrect the Rx-reimportation law.
The FDA is investigating bogus lots of Epogen (epoetin alfa) and Neupogen (filgrastim), both made by Amgen; Serostim (somatropin, Serono); and Nutropin (somatropin, Genentech) all discovered this year. At the same time, House Energy & Commerce Committee staffers discovered that as many as 700 packages a day containing pharmaceuticals were being held by the U.S. Customs at one mail facility while the FDA was able to process only 30 of them to see whether they were legitimate or otherwise legal.
"Do thousands of packages, even if initially detained by Customs, simply get delivered to the addressee without review?" asked committee chairman W. J. "Billy" Tauzin (R, La.). A hearing has been scheduled for answers.
HHS secretary Tommy Thompson has been hinting for weeks that he probably will go along with the recommendation of his predecessor, Donna Shalala. She decided the FDA could not ensure the quality of the drugs that pharmacists and wholesalers would be eligible to reimport. Thompson has promised a decision by June 30. Supporters of reimportation have vowed to push legislation remedying any defects found by Thompson.
In January, Sen. Thomas Daschle (D, S.D.) introduced Medicare pharmacy benefit legislation that called for pharmacy freedom of choice, payment for pharmacist services, and contract negotiations between groups of pharmacists and PBMs. But with the GOP in control of the Senate, Daschle's bill was unlikely to get a hearing, much less a favorable vote.
Now Daschle is the majority leader of the Senate, and his Democrats have the power to hold hearings and schedule votes. The change, thanks to Vermont Sen. Jim Jefford's decision to abandon the GOP and become an independent, does not guarantee Daschle's bill or any other Medicare prescription plan will pass the Senate. But it does mean those proposals favoring heavy reliance on PBMs and mail-order incentives will not top the agenda.
Mike Conlan. Capital Capsules. Drug Topics 2001;11:19.