FDAnews Drug Daily Bulletin


April 21, 2006

Senators Chuck Grassley (R-Iowa), Max Baucus (D-Mont.), Orrin Hatch (R-Utah) and Jay Rockefeller (D-W.Va.) petitioned HHS Inspector General Daniel Levinson to address drug companies participation in patient assistance programs (PAPs). The HHS should provide definitive guidance to drugmakers, said the senators, ensuring that patients with extraordinary healthcare needs remain able to participate in PAPs even after signing up for the new Medicare prescription drug benefit. Help may be discontinued for certain patients, the senators worried, after May 15 -- the deadline for Medicare recipients to sign up for the new benefit.

"PAPs provide free or subsidized medications to thousands of individuals, including Medicare beneficiaries, who might not otherwise be able to afford their prescription drugs, even if they are enrolled in the new Medicare prescription drug benefit," states the letter.

"We have been pushing for a resolution on this issue since November," added Rockefeller. "We are less than a month away from having some drug companies terminate these vital programs Nothing short of an immediate and complete clarification of these rules is acceptable."

In response, Levinson's office issued an advisory opinion to one drug company -- its name withheld from the public -- that had requested PAP clarification. This action was largely welcomed by the senators.

"I'm glad the HHS was able to advise one drug manufacturer on how to continue its patient assistance program in conjunction with the benefit," noted Baucus. "It's good that the pharmaceutical manufacturer involved has found a way to continue providing this much-needed assistance, and I hope that others in the industry can do the same so that Medicare beneficiaries can get the drugs they need."

There are roughly 180 PAPs in effect, providing billions of dollars in free medicine to beneficiaries. These programs help fill gaps in coverage for patients facing out-of-pocket costs but do not qualify for Medicare's low-income assistance. (http://www.fdanews.com/did/5_78/)