Jill Wechsler
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Democrats are back on top in Congress after more than a decade as underdogs. The new leaders are mapping out a broad agenda—with
drug pricing and access high on the list.
One top priority for new House speaker Nancy Pelosi (D-CA) is to repeal Medicare's "non-interference" clause, which prevents
the government from negotiating for lower drug prices directly with pharmaceutical companies.
There's reason to believe that government negotiation will do little to bring down prices. Moreover, as Ken Johnson, senior
vice president of PhRMA, points out, the non-interference policy also prevents the federal government from limiting patients'
access to needed medicines. But repeal was a popular promise that the Democrats will try hard to fulfill as they gear up for
the 2008 presidential campaign.
Access to drugs also means filling in the much-maligned "doughnut hole" in Medicare Part D. And legislators could try to make
it easier for Americans to obtain low-cost drugs from other countries. Even though Congress included a drug importation provision
in a recently enacted spending bill, many state and federal policy makers want broader access to cheap drugs from abroad,
no matter what the potential for safety and quality problems.
Local Initiatives
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Pharmaceutical and biotech companies may be more enthusiastic about Pelosi's promise to expand federal support for stem-cell
research. But increased funding for biomedical research won't do much good if added regulation and price controls dry up financial
investment in the biotech industry, points out Jim Greenwood, president of the Biotechnology Industry Organization (BIO) and
formerly a leading Republican on the House Committee on Energy and Commerce.
"We need to persuade the new leadership that when they're making speeches on stem-cell research, they have to make sure that
biotech companies will be there to develop the promised new cures," says Greenwood. "We need to protect the biotech goose
laying the golden eggs."
Push for PDUFA
While industry may succeed in blocking changes in Medicare, the much more difficult task is to gain approval for important
desired legislation. Congress has to reauthorize the Prescription Drug User Fee Act (PDUFA) before the program expires September
30, 2007. And legislation is needed to continue the highly regarded pediatric drug-exclusivity program.
To reach agreement on this must-pass legislation, pharma has to work with some of its sharpest critics—Reps. John Dingell
of Michigan and Henry Waxman of California, both key players in shaping the original user-fee program some 15 years ago. Dingell
is slated to chair Energy and Commerce, which oversees FDA and most healthcare issues, and he is already mapping plans for
aggressive oversight of FDA and the Part D drug benefit, which he strongly opposed.
New Faces in Charge
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Waxman will play a key role in negotiating PDUFA issues as a senior Democrat on Energy and Commerce, while also investigating
industry practices and FDA programs as chairman of the House Government Reform Committee. Even in the minority, Waxman used
his position on this panel to launch investigations and issue reports on drug safety and marketing. Waxman is a strong advocate
for generic drugs and recently joined key Senators to introduce legislation establishing a pathway to approve generic versions
of biotech therapies.
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