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US post-election buzz: a tale of stem cells, trade agreements and power struggles

One week after US voters elected Illinois Democratic senator Barack Obama as their next president, we offer a few interesting post-election tidbits on which Scrip's Washington bureau is keeping an eye (and that don't involve use of a crystal ball or an Ouija board to divine the name of the next FDA commissioner).

Racing to renew stem cell research: Both president-elect Obama and congressional Democrats want a hand in quickly eradicating federal funding restrictions for embryonic stem cell research, that have been in place since 2001. Mr Obama's transition team leader, John Podesta, told the Fox News Sunday television programme that the stem cell restrictions are among many Bush Administration policies that could be reversed through an executive order by the new president.

"There's a lot that the president can do using his executive authority without waiting for congressional action," Mr Podesta said.

House speaker Nancy Pelosi has cited increased stem cell research funding as a Democratic legislative priority in the first 100 days of the new Congress. So, who will make the first move to eviscerate President George Bush's unpopular restrictions?

One theory is that after taking office on January 20th, Mr Obama will quickly sign an executive order lifting the restrictions, with Congress subsequently moving to legislate and fund expanded research and set ethical conditions on how it should be carried out.

Trade agreements: Word in Washington is that the Bush White House might be willing to go along with another domestic economic stimulus package when Congress reconvenes for its lame-duck session in the week of November 17th, but only if the Colombia free trade agreement is attached to the deal.

The Colombia FTA has languished since April, when House Democrats blocked Mr Bush's effort to force an up-or-down vote on the pact within 90 legislative days. Trade agreements with Panama and South Korea also are pending.

No deal, Mr Obama's soon-to-be chief of staff Rahm Emanuel told ABC News' "This Week with George Stephanopoulos". Mr Emanuel, a congressman from Illinois and part of the current Democratic leadership in House, said "You don't link those essential needs to some other trade deal."

Democratic power struggles: A nasty leadership fight is shaping up in the House energy and commerce committee, which oversees the FDA and has been a thorn in the pharmaceutical industry's side since Democrats retook control of the chamber two years ago.

Big pharma foe Henry Waxman of California is trying to wrest control of the panel from the hands of Michigan congressman John Dingell, the panel's long-time Democratic leader. Mr Waxman currently chairs the oversight and government reform committee.

A long-time friend of the generics industry, he has introduced biosimilars legislation that would give innovators no additional marketing exclusivity and staunchly opposed the FDA's views favouring pre-emption of product liability claims based on the adequacy of a drug's labelling. He is also developing legislation to apply Medicaid's statutory drug pricing limits to certain medicines in the Medicare Part D programme.

Under Mr Dingell's chairmanship in the past two years, the energy and commerce panel and its subcommittees have conducted multiple investigations and hearings spotlighting problems with the FDA's oversight of foreign drug manufacturers and abuses of industry promotional practices, particularly direct-to-consumer ads.

However, the committee put the brakes on speeding biosimilars legislation to passage in 2007, instead issuing information requests to industry and other stakeholders on the subject. It seems the innovative industry would have a much tougher battle ahead on biosimilars legislation if Mr Waxman takes the helm at energy and commerce.

Posted 11/11/2008 12:54:35 PM
by Sue Sutter,
Washington Editor

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