Turning Off The Runway Lights At HHS

If the wide variety of health care reform proposals swirling around Washington ever coalesce into legislation that is signed into law, HHS will have dozens of new responsibilities. But sponsoring fashion shows would no longer be one of them, if Sen. Coburn has his way.

The fiscally conservative Republican from Oklahoma is sponsoring a health reform amendment to prevent HHS from using funds to sponsor fashion shows; the amendment will be considered during markup of the Senate Health, Education, Labor and Pensions health care reform bill, known as the “Affordable Health Choices Act,” which begins June 17.

Coburn has long had a beef with HHS spending money on the lights and glamour of the runway, as expressed a number of times on his web site, including in a statement protesting HHS sending dozens of employees to a conference at a beach resort where the entertainment included a “sizzling fashion show.” He also has questioned why money is being spent on social events, including fashion shows, to raise awareness of the search for an HIV vaccine when that money could be used to actually conduct research on a vaccine.

As Coburn put it in a 2008 press release: “Who knows what scientific discoveries could be unlocked at a bar or fashion show! But with your tax dollars, we will find out!”

image from flickr user maddsmadds used under a creative commons license

Senate Decides Health Reform Isn't The Time To Have The Viagra Talk

Senate Republicans this week made a vigorous, though as expected unsuccessful, last ditch bid to stall the health care reform package, offering a slew of amendments of the final budget reconciliation piece of the package.

But amidst all the sweeping soliloquies about how health reform will inflict significant damage to the health care system, rest assured that one man, Sen. Tom Coburn, is keeping watch as well on some of the most arcane details.

The Oklahoma Republican offered an amendment March 25 that would restrict sex offenders' access to erectile dysfunction drugs like Viagra. It was one of 40-plus amendments were crafted specifically to make it difficult for Democrats to vote "No."

IN VIVO Blog readers may recall this is not the first time that Coburn has lobbed up an amendment to ward off misspending of health care dollars. When the Senate Health Committee was debate health reform last June, he unveiled a proposal to prevent HHS from using federal funds to sponsor fashion shows intended to raise awareness of health issues.

Now his fiscal conservatism has gone a little more hard core. Coburn's "No Erectile Dysfunction Drugs To Sex Offenders" (Amendment 3556) would prohibit federal payment for Pfizer's Viagra and other ED medications like Lilly's Cialis and Bayer's Levitra for convicted child molesters, rapists, and sex offenders. It also would prohibit coverage of abortion drugs and enact Government Accountability Office recommendations to prevent fraud via insurance claims for prescriptions written by providers who are actually dead or provided to dead patients.

It's hard to argue that sex offenders or dead people need access to ED drugs, but Finance Committee Chairman Max Baucus, D-Mont., called the amendment a "crass political stunt aimed at making 30-second commercials." Health reform "is a serious bill," Baucus said. "This is a serious debate. The amendment offered by the senator from Oklahoma makes a mockery of the Senate, the debate and the American people." The amendment was defeated 57-42.

ED drugs recurringly draw the ire of legislators, who have often prodded the Centers for Medicare & Medicaid Services to limit federal payments for such products. Since 2007, for example, CMS has instructed that such drugs are not covered by Medicare Part D for the treatment of sexual or erectile dysfunction (Pfizer markets Viagra's active ingredient sildenafil under the trade name Revatio for pulmonary arterial hypertension; that type of use is covered).
Part of the problem may be that legislators don't like ED advertisements and often try to curb them. (Alas, no fond memories of Bob Dole's time in office?) Last year, for example, House Democrat Jim Moran introduced legislation that directs the Federal Communications Commission to consider any advertisement for ED treatment or male enhancement as indecent for purposes of broadcasting between 6 a.m. and 10 p.m. Pfizer's current TV ads ask "Isn't it time you had the Viagra talk?

Despite such diversions, the Senate cleared the reconciliation bill later the same day. (For a recap of key pharma provisions, see last week's issue of "The Pink Sheet".) A couple minor education-related provisions were deleted, so the measure will need one final House vote. Meanwhile, we are eager to see what sizzling issues Coburn may similarly detect in upcoming legislative initiatives like financial reform.

- By Lauren Smith

The Return of Henney?

Great little story from Bloomberg on the possibility of former FDA Commissioner Jane Henney returning to FDA in the same role. To read it, click here. This is just the type of story we love to read, so cheers to Bloomberg on this one.

We heard the rumor about a month ago that Jane Henney, not David Kessler, would be the most likely former commissioner to go back to FDA, but "Jane isn't campaigning for the job," a person close to the transition told us. That may be the perfect strategy to getting the job. Kessler, the person says, still has left too many hard feelings among the Republican leadership on Capitol Hill.

Regarding the Henney situation, what we have heard is there are at least two women's groups pushing for former FDAer and George Washington school of public health professor Susan Wood as FDA Commissioner. As we've reported before, Wood was a big Hillary Clinton supporter. To read our earlier Hillary Clinton's FDA post and get a little background, click here. Wood was co-chair of the women's health policy advisory group during the Obama campaign after Hillary lost, which no doubt improves her chances to lead FDA.

The groups pushing for Wood apparently have Henney as their second choice. As we were reminded by a close friend, that's how Abraham Lincoln became President (read your Team of Rivals, people!).

The crux of the Bloomberg story is this:

"An Obama representative asked Henney, who was commissioner from November 1998 until January 2001, if she was interested in the job, and she said yes, according to a person familiar with the matter."

The name for everyone to remember when it comes to FDA and other major agency positions is this one: Don Gips. The former Level 3 Communications VP is the new director of White House Personnel. There's a little bit on him here. There is little chance anyone will be tapped as FDA commissioner without talking to Gips first. It's possible Henney interviewed with Gips during the campaign (he also helped Obama put together his Senate staff) but we find that unlikely. Gips was just recently named to the job so we doubt he's had a chance to interview many, if any, commissioner candidates.

It's unclear when Obama will name the next FDA Commissioner (you can read our story on the interim commissioner by clicking here.). For example, we know that at least one leading commissioner candidate has yet to be contacted by Gips. We've heard that if the administration wants to act quickly, an announcement will be made at the end of the month or the first two weeks of February and a hearing will be scheduled for April/May. A slower vetting process would mean a Senate confirmation hearing wouldn't occur until Fall 2009.

If the administration goes with Henney, it would be the safe pick. She knows the agency and knows many of the people in leadership positions. She would also generate little opposition. That doesn't mean there wouldn't be any opposition.

Sen. Tom Coburn (R-Okla.) would likely put a hold on her nomination because of her role in approving RU-486. The current University of Cinncinnatti SVP and Provost for Health Affairs also would have to explain her involvement in regulated industry. According to her biography on the site, Henney has served on a variety of boards of directors in the health care field, including the Commonwealth Fund in New York City, the Scripps Research Institute in La Jolla, AmerisourceBergen Corporation in Philadelphia, AstraZeneca PLC in London, the Science Board of MPM Capital in Boston, and the Advisory Group to the Pew Science and Society Institute.

Still, we think she would get through the nomination process. And the folks in Washington policy circles certainly have taken notice that Henney's name is out there.