It has been a difficult year at the Food and Drug Administration. After months of turmoil over drug safety, vaccine shortages,
and demands for low-cost drugs from abroad, commissioner Lester Crawford resigned abruptly in September, generating considerable
uncertainty about the future leadership of the agency.
The White House quickly named an acting commissioner: Andrew von Eschenbach, director of the National Cancer Institute (NCI)
at the National Institutes of Health (NIH). But Eschenbach got into trouble almost immediately for trying to keep his NCI
hat while taking the helm of FDA. He handed over day-to-day leadership of NCI to a deputy, but that temporary move failed
to fully appease some congressional critics—who are concerned there is an inherent conflict of interest when an advocate for
speedy access to new cancer treatments also has the job of overseeing the safety and effectiveness of those therapies.
Von Eschenbach may be a reasonable choice to head FDA, but the word is that the White House does not plan to nominate him
as permanent FDA commissioner. A cancer specialist from the M.D. Anderson Cancer Center in Houston before coming to NCI in
2002, he has made friends at FDA by supporting NCI-FDA collaboration on biomarker validation and personalized medicine.
At FDA, though, such promising initiatives have taken a back seat to dealing with daily crises. Battles continue over the
morning-after pill—Barr/Duramed's Plan B (levonorgestrel)—as well as the regulation of follow-on biologics. Serious concerns
have emerged over the safety and testing of implantable medical devices, and the job of maintaining the safety of the nation's
food supply is, as always, monumental.
The clouded circumstances of Crawford's departure may complicate the process of securing a permanent FDA leader. Congress
and HHS's Inspector General are investigating whether the Senate failed to uncover important information during Crawford's
confirmation process. This may result in even more rigorous scrutiny of any future nominee. Meanwhile, Senate Democrats insist
that the FDA commissioner be completely free of pharma company influence, while Republicans want someone who fits their political
agenda. Current FDA officials are linked too closely to recent agency missteps to be confirmed.
NCI-FDA collaborations have increasingly included the Centers for Medicare and Medicaid Services (CMS), which has been taking
on a more visible role in assessing the value of medicines for payers and patients. FDA and CMS officials have discussed ways
to better coordinate new drug approvals with Medicare coverage decisions—a development that will have a broader impact as
the Medicare drug benefit gives government (federal, state, and local) control of more than 40 percent of the prescription
drug market, up from about 25 percent today. At the same time, growing pressure from conservative Republicans to cut costs
in the wake of the Gulf hurricanes and the continuing war in Iraq will intensify efforts to reduce the cost of the multi-billion-dollar
Medicare program. This means expanded comparison of drug effectiveness and safety, along with efforts to ratchet down prescription
Federal and state officials thus are looking closely at how pharma companies negotiate contracts and calculate rebates and
discounts with the insurers and pharmacy benefit managers (PBMs) that have lined up to offer national and regional prescription
drug plans (PDPs) to the nation's elderly. The Medicare drug benefit will have a major spillover effect on the commercial
pharmaceutical market, says consultant Alex Vechon of Hamilton PPB. It already is reshaping business alliances, as PBMs link
up with retail pharmacies and health insurance giants, and it promises to create volatility in pharma industry stock prices.
Lots of Players
So far, the early fear that PBMs would not assume risk in offering Medicare drug coverage has not materialized. Hundreds of
private insurers and Medicare Advantage prescription drug plans (MA-PDs) are marketing drug benefits at unexpectedly low prices
to gain some piece of the action. Ten companies are providing drug plans on a national basis, which means "there will be no
fall-back plans anywhere," as CMS administrator Mark McClellan put it: CMS will not have to provide backup drug coverage for
seniors unable to access a PDP.