Bart Stupak

FDA handed out $35M in bonuses

Tracy Staton — Thu, 26 Jun 2008 10:03:05 -0400

The FDA finds itself in the line of Congressional fire on two different issues today. One, the agency is taking some heat for the $35 million in incentive pay it handed out last fiscal year, a 29 percent hike from the year before. Rep. Bart Stupak, a familiar FDA critic and head honcho of a House panel reviewing FDA compensation, called the bonus increases "outrageous" in light of "the agency's poor management."

The bonus plan has been around since 2004--as a way to compete with the private sector for top talent--but last year marked the biggest payouts; some FDAers got more than $50,000 in incentive pay. And 17 of the highest paid officials at the agency made more than $200,000. That's more than a member of Congress or the U.S. attorney general takes home.

Meanwhile, the agency's animal health division is facing more questions about the return of ProHeart 6, Wyeth's heartworm med that was yanked four years ago after it was linked to serious side effects. Stupak and his colleague John Dingell want the FDA to justify its decision to let the drug back onto the market, saying that ProHeart 6 didn't get a full safety-and-risk evaluation before the go-ahead came.

- read the Wall Street Journal story
- see the item at the WSJ Health Blog
- check out the Pharmalot post

Drugmakers to delay new-drug ads

Tracy Staton — Tue, 17 Jun 2008 09:25:00 -0400

There's a waiting period for marriage licenses, IPOs, and flood insurance--and now, drug advertising. Several big drugmakers called on the Congressional carpet for their advertising campaigns now say they'll wait six months after FDA approval to start touting new meds to the public. They also said they'd follow AMA guidelines for using actors to play doctors on TV.

But Michigan Dems Bart Stupak and John Dingell aren't satisfied with these concessions. They'd asked for a two-year waiting period, for one thing. And as Merck explained in a letter to the House Committee on Energy and Commerce, a six-month quietus after FDA approval is already somewhat customary, because drugmakers like to educate docs about new products before driving patients into their offices with DTC ads. The committee also had asked the companies to advertise drugs only when they've proven effective in outcomes studies.

You'll recall that Stupak and Dingell have been breathing down pharma's neck all year, with hearings on everything from clinical trials to outsourcing to, of course, DTC advertising. The DTC hearing focused on Pfizer's Lipitor ads starring artificial-heart inventor Robert Jarvik, on Johnson & Johnson's commercials for the anemia treatment Procrit, and Merck and Schering-Plough's food-and-family ads for their combo cholesterol med Vytorin.

- see the committee's statement about the six-month wait
- check out the Advertising Age story
- find the post at the Wall Street Journal Health Blog

Congress asks CEOs to pledge truth in DTC

Tracy Staton — Wed, 21 May 2008 10:24:15 -0400

Dingell and Stupak strike again. Fresh on the heels of their DTC hearing, the two Congressmen have issued letters to four top pharma execs--CEOs at Merck, Pfizer, Schering-Plough, and Johnson & Johnson--asking them to commit to honest-Abe advertising. "Consumers should not have to rely on the oversight function of Congress to make sure drug companies tell the truth in their ad campaigns," Stupak said, calling DTC advertising a "privilege" that comes with responsibility.

The two men also question the industry's own DTC guidelines. In a separate letter to the Pharmaceutical Research and Manufacturers of America, they say that the guidelines should be updated. Among the suggested changes: Ads for drugs with "black box" warnings have to specifically include that cautionary tale.

- check out the House Energy and Commerce Committee's release
- get the article at CNN Money
- see the story in PharmaTimes

Stupak: FDA needs subpoena power

Tracy Staton — Tue, 20 May 2008 10:05:12 -0400

Rep. Bart Stupak (photo) might be a severe FDA critic, but he's also shaping up to be the agency's dearest friend. Chief of the House Energy and Commerce committee's oversight-and-investigations group, Stupak helped push FDA commissioner Andrew von Eschenbach to ask for millions more in FDA funding--and now he's suggesting that the FDA needs subpoena power. That's no small thing; it would allow the FDA to demand documents from drugmakers rather than simply ask nicely and say please.

Apparently, Democrats on the committee have been rankled by the FDA's lack of power in that department because they think it has limited the agency's pharma investigations. During a recent hearing, Stupak asked CDER honcho Janet Woodcock and her deputy whether they'd like subpoena power; they agreed it would be "very useful." Now, Stupak has written to von Eschenbach asking his opinion on the potential change. He'd like to add it to a drug importation bill now pending in the House. No word on what the commish plans to say in response.

- read the WSJ Health Blog item

Did FDA counsel save Procrit ads?

Tue, 13 May 2008 06:59:56 -0400

Remember that DTC hearing in Congress last week, when Rep. Bart Stupak alleged that Johnson & Johnson kept pushing its anemia drug Procrit as a fatigue-buster, despite the FDA's admonitions? Testimony on the subject came with a bunch of documents, which The Cancer Letter dug through--to find that the FDA's chief counsel may have intervened on J&J's behalf to keep the ads on the air.

The agency had questioned J&J's advertising, saying its implication that Procrit improved strength and perhaps survival was misleading. Somewhere along the line, the Office of Chief Counsel became involved; notes from a 2002 teleconference show that the OCC asked the staff to "try to find middle ground" and to avoid "yanking" the ad campaign. (The chief counsel at the time of the teleconference is now in private practice.) The ads continued to run through 2005. Experts told The Cancer Letter that they think the episode should be reviewed by agency ethics officials.

Meanwhile, a Government Accountability Office report shows that the FDA drags its heels on issuing warning and untitled letters about DTC ads: Six months on average, and in one case, more than three years. Before 2002, when the FDA decided to submit all draft letters for legal review--by the Office of Chief Counsel--they went out in less than a month.

- find the GAO report here
- see the brief in The Cancer Letter
- get more from Pharmalot
- check out the article at FDA News

Politics hampers heparin probes

Mon, 12 May 2008 06:59:57 -0400

On the one hand, we have Health and Human Services Secretary Mike Leavitt gladhanding Chinese officials as he announced the heparin supply is now safe--including the crude heparin coming from China's workshops. On the other, there's Rep. Bart Stupak (photo), whose congressional committee is investigating the heparin debacle, contending that, "The FDA thinks they have it under control, but they really don't. If I was the FDA director, I'd shut down every drug coming in from China" until they were deemed safe, he told the Wall Street Journal.

Stupak is riled because the FDA won't hand over the names of Chinese heparin suppliers, citing confidentiality agreements. He and his committee worry that Chinese companies aren't fully cooperating with the agency's probe; during recent testimony, an FDA inspector said Chinese manufacturers didn't give them complete access to suppliers of crude heparin. Of course, Chinese officials accused Baxter of stonewalling their investigation, too.

All of which shows that politics is clouding the process of tracing contaminated heparin back to its source or sources--politics that go way beyond the typical Democrats-versus-Republicans grandstanding in our nation's capitol. Because this investigation crosses international boundaries, inspectors are hamstrung by deals higher-ups made on their behalf. As the top brass are smiling and making promises, the on-the-ground investigators are fighting red tape. Yet another unforeseen consequence of the globalization of pharma.

- read the article in the Wall Street Journal
- see Leavitt's pronouncement
- check out the UPI story

ALSO: The FDA sent out a new round of alerts to hospitals, pharma groups, and medical societies after learning that some medical facilities still had contaminated heparin among their supplies. Report

AMA calls for tighter DTC regulation

Fri, 09 May 2008 06:59:57 -0400

We all expected Democrats to rake DTC ads over the coals during yesterday's hearing before the House Energy and Commerce Committee's oversight arm. We expected Chairman Bart Stupak to call for tighter controls on the ads. What we didn't expect was for the American Medical Association to join the fray. President-elect Nancy Nielsen told lawmakers that the FDA should be given more authority to pre-approve DTC ads. Striking directly at drugmakers' usual defense of the ads as "educational," Nielsen said, "It is frankly clear that the majority of what's happening has a marketing effect and not an educational effect."

Nor did we know that the feds' own watchdog, the Government Accountability Office, would say the FDA isn't completely effective at regulating those ads; the agency takes more than six months to issue warnings about ads that violate the rules.

During the hearing, ads such as those for Merck/Schering-Plough's Vytorin and Johnson & Johnson's Procrit were called misleading and not completely truthful. Pharma officials struck back, saying that the claims made in those ads were "supported by research" (M/S-P) and "true, responsible, and substantiated by scientific studies" (J&J). And Republicans on the committee said the (unfunded) standards Congress set last year for drug commercials should be paid for and given a chance to work.

- read the AMA's press release
- see the story from ABC News
- check out the USA Today piece
- read the Star-Ledger article

ALSO: The feds need to add rules governing drug product placements, too, according to a report from University of California-Los Angeles researchers. Report

Will DTC hearing lead to new regulation?

Thu, 08 May 2008 06:59:56 -0400

Will today's Congressional hearing on drug ads lead to new legislation? That's what Michigan Democrat--and vocal pharma critic--Bart Stupak (photo) hopes. The chairman of the House Energy and Commerce's subcommittee on oversight says he'd like to tighten controls on drug marketing to consumers. For one thing, he'd give the FDA power to force changes in TV ads before they're aired.

Of course, Congress has tried before to stiffen DTC rules, but the TV industry--which reaps billions from the ads--and pharma lobby have fended off those changes. But several recent controversies may aid the reform cause this time. Merck and Schering-Plough have drawn fire for heavily promoting their Vytorin cholesterol drug while dragging their feet on data that questioned its effectiveness. Pfizer pulled its Lipitor campaign when critics assailed its use of artificial-heart inventor Robert Jarvik. And then, says Stupak, there's Johnson & Johnson, which advertised its anemia med Procrit as an anti-fatigue drug, a use for which it was not approved. The FDA repeatedly asked J&J to revise those commercials, but the company didn't. Stupak told the Wall Street Journal: "They advertised this for seven years."

J&J disputes that assertion, saying that the commercials were accurate and consistent with their FDA-approved labeling at the time. But expect to hear more argument of these points during today's hearing, which you can watch on the committee's website, among other places.

- see the Wall Street Journal article
- find the video link at the committee website