John Dingell

Daschle, Waxman nab pharma oversight power

Tracy Staton — Fri, 21 Nov 2008 11:05:37 -0500

We still don't know who might take the reins at FDA, but a couple of other key Washington posts appear to be filled. First, there's Sen. Tom Daschle, former Majority Leader, who's been nominated to run HHS (or so sources tell a variety of newspapers, including the Washington Post). And then there's Rep. Henry Waxman's upset takeover of the House Energy and Commerce Committee, which oversees the FDA and the drug and device industries, among many others.

Many see Obama's choice of Daschle as a major signal that, despite our current economic woes, healthcare reform is far from last on the President-elect's to-do list. Daschle is likely to not only take the helm at HHS, but to play a role as White House liaison to Congress on healthcare reform legislation. In fact, that role as top WH adviser on healthcare was key to Daschle's acceptance of the job, sources tell the Post. "Being a Cabinet secretary is a car and driver and you get to go to the head of the line at the airport, unless you're Defense or State," said one Daschle associate. "This was key for Tom to have that White House connection."

What does this mean for the FDA? Probably nothing more than what we already know: that the new HHS secretary will be under major pressure to revitalize the much-maligned agency. But with Daschle focusing on comprehensive healthcare reform, FDA change will be only part of the overall package. We might expect moves toward comparative efficacy in pharma as well as non-pharma treatments--similar to but not exactly like U.K.'s NICE--and a push for the FDA to regulate tobacco. We can also anticipate confirmation-hearing questions about the lobbying Daschle's law firm--and his wife Linda--have done on behalf of various drugmakers.

As for Waxman's ascendance at Energy and Commerce, don't expect the committee to lighten up on drugmakers. Despite the fact that Waxman's getting more attention for the fact that he's greener on energy than his predecessor John Dingell, you in pharma know that like Dingell, he's been an outspoken critic of drug and device makers. A couple of his pet issues have been preemption (he's against it) and off-label marketing restrictions (he's for them).

- see the WaPo story
- check out BNet's assessment of Daschle and his clients
- read the WSJ Health Blog's Waxman post

Pharma critics vie for House chairmanship

Tracy Staton — Mon, 10 Nov 2008 11:39:55 -0500

Two Congressional bulldogs are playing King of the Hill. Reps. John Dingell and Henry Waxman are battling over the top slot at the House Committee on Energy and Commerce, a key health policy committee.

Dingell is the current chairman, and under his leadership the committee and its subsidiary, the subcommittee on investigations, have been a thorn in the side of FDA and industry alike. Dingell and his investigations chair, Rep. Bart Stupak, have gone after Merck and Schering-Plough over the embattled cholesterol med Vytorin. They've harassed Bayer and Amgen about marketing practices and chastised DTC advertising in general. They've raked the FDA over the coals, too.

Waxman is already on the committee, and he chairs the House Committee on Oversight and Government Reform. He, too, has plagued pharma with criticism of everything from Medicare Part D to a potential loosening of off-label marketing rules. He's challenging Dingell for the chairmanship of Energy and Commerce simply because he thinks it's time for new blood. Dingell has been the committee's top-ranking Democrat for 28 years, Waxman says.

Dingell won't go quietly, though. He's campaigned to keep the slot by emphasizing his committee's record at getting legislation through the House--91 bills over the past two years, with 27 signed into law. Stay tuned.

- read the WSJ Health Blog post

House, Senate hook up on DTC ads

Tracy Staton — Mon, 29 Sep 2008 10:34:42 -0400

DTC ads may have performed a minor miracle. The U.S. House and Senate appear to be poised to work together. Yes, these perennial competitors could join forces on investigating consumer advertising for drugs and medical devices. Sen. Herb Kohl, chairman of the Senate Special Committee on Aging, wrote to Rep. Bart Stupak, who chairs the Subcommittee on Oversight and Investigations, offering to add his device-ad evidence to Stupak's growing body of data on drug ads. "We would welcome any further exchange of information with the Subcommittee on this important matter," Kohl wrote, "and we stand ready to work with you and your able professional staff in addressing these DTC advertising issues in a cooperative and bicameral manner."

As you know, Stupak and his buddy Rep. John Dingell, who chairs the House Energy and Commerce Committee, have been firing off letters to all and sundry in the pharma world, seeking information about various DTC ad campaigns. They've held hearings. They complained so loudly about Pfizer's Lipitor campaign starring Dr. Robert Jarvik (video) that the drugmaker eventually yanked the commercials altogether.

Kohl started to apply the same sorts of pressure on device advertising, and his bid for equal-investigative-treatment is one reason he's contacted Stupak. Device ads should carry the same regulatory oversight as drug ads, Kohl theorizes, so let's all work together and sock it to them! Whether the joint effort steps up the pressure or not, you can be sure that the scrutiny will continue.

- read the story at Medical News Today

Peto bristles at Vytorin-cancer questions

Tracy Staton — Fri, 19 Sep 2008 10:09:03 -0400

Sir Richard Peto takes umbrage at the idea that he might skew a statistical analysis to benefit a drugmaker. The eminent Oxford statistician, as you know, recently weighed in on a study that seemed to link the Merck/Schering-Plough cholesterol med Vytorin with an increase in cancer cases and deaths. Peto concluded that the apparent risk was a statistical anomaly, a freak of chance.

Now, Peto is defending that conclusion against the opinions of other experts and questions from the U.S. Congress. In a letter to Reps. John Dingell and Bart Stupak, who are investigating the Vytorin controversy, Peto asserted that "any competent trial statistician" would agree with his analysis. Suggestions that he might bias his work in favor of Merck and Schering-Plough are absolutely wrong: They don't pay his salary and had no impact on his analysis of the trial data.

Apparently, Peto takes a dim view of the competency of the New England Journal of Medicine and its experts. Two NEJM editorials recently critiqued Peto's analysis, saying that an increased risk of cancer death in Vytorin patients can't be ruled out. Peto hasn't specifically addressed their conclusions--yet.

- read the Forbes story
- check out the Wall Street Journal Health Blog post

FDA probes Vytorin cancer risk

Tracy Staton — Fri, 22 Aug 2008 10:32:13 -0400

Yesterday, a study appeared to clear statins of their possible link to cancer. But today, the FDA says it's investigating whether the cholesterol-lowering drug Vytorin can boost the risk of developing that disease. What gives? Well, for one thing, Vytorin isn't just a statin; it combines Zocor with Zetia, a drug that lowers cholesterol via a different mechanism. And the agency is following up on a trial, called SEAS, in which Vytorin-taking patients seemed to have a higher risk of not only developing cancer, but dying from it.

And the FDA is doing so under political pressure, we might add. As soon as Merck/Schering-Plough announced the results of that trial--which, in addition to flagging a possible cancer risk, showed Vytorin didn't affect heart-valve disease any more than placebo did--it trotted out a big cancer expert who concluded that the risk was probably an anomaly. But some experts weren't convinced, and neither were Reps. John Dingell and Bart Stupak, the frequent pharma critics on the House Energy and Commerce Committee. They demanded to look at the cancer data themselves. Yesterday, the Congressmen heard from the FDA about that data, and immediately dispatched letters to Merck and Schering-Plough asking for the cancer expert's analysis. They also asked for proof that the expert was truly independent.

The FDA, for its part, cited two other studies that contradict the SEAS data on cancer risk. And the agency says it will take about nine months to sift through all the avaiable info to determine just what, if any, cancer risk Vytorin carries. Stay tuned.

- see the Washington Post story
- read the Wall Street Journal article

Congress wants Vytorin analysis

Tracy Staton — Fri, 01 Aug 2008 10:44:29 -0400

Congress wants to get its hands on the latest Vytorin data. The House Energy and Commerce Committee is asking the FDA to fork over an analysis of the recently released SEAS trial, which ended up being a double whammy for Merck and Schering-Plough: Vytorin did no better than placebo at reducing the narrowing of heart valves, and researchers found an unexpected increase in the risk of dying from cancer.

You'll recall that the company called on an eminent cancer epidemiologist to analyze data on that risk, and that expert concluded that it was probably an anomaly. Well, the committee--chaired by Rep. John Dingell--wants to see the evidence for itself. The FDA, which was given a copy of that analysis, says it's reviewing the document request. You can bet that if the agency hands it over, we'll soon hear more from Dingell & Co.

- see the Wall Street Journal story
- check out the WSJ Health Blog post

House votes to treat tobacco as a drug

Tracy Staton — Thu, 31 Jul 2008 10:10:40 -0400

If the U.S. House gets its way, the FDA soon may have even more power--to regulate tobacco as a drug. Reps voted overwhelmingly to charge the agency with overseeing the tobacco industry, in spite of a veto threat by President Bush. It's a move long sought by anti-smoking advocates, and one lobbied for, as you may recall, by ex-FDA chief David Kessler.

Under the bill the agency would be able to reduce the amount of addictive nicotine in cigarettes and smokeless tobacco--though not remove it altogether--plus ban various additives, such as candy and fruit flavorings designed to appeal to youngsters. And tobacco makers would have to disclose all the different additives in their products and hand over research into their effects.

In declaring its opposition, the White House said that the FDA is already overstretched as it is. But that didn't seem to bother frequent agency critic John Dingell, a vehement supporter of the measure. It's not clear as yet whether the Senate can come up with a veto-proof majority for the bill. Stay tuned; it's sure to cause lots of debate.

- read the Washington Post story
- see the article in the New York Times

Grassley, Dingell plan FDA renovation

Christe Bruderlin-Nelson — Wed, 30 Jul 2008 08:12:14 -0400

A pair of FDA critics, Rep. John Dingell (D, MI) and Sen. Chuck Grassley (R, IA), are making it a major priority to overhaul the FDA and give the organization additional power, as well as to draw a deeper line in the sand between the agency and the industry it regulates. Grassley says that agency officials "are too cozy with the companies they regulate."

Both men would like to broaden FDA's recall powers and to increase the agency's ability to impose fines and restrict pharma advertising. However, with not much time before the November elections, some of their plans will likely have to wait.

The pair will make efforts to address what they consider mishandlings of events by the FDA, such as the jalapeño salmonella outbreak that was originally blamed on tomatoes. Drug controversies abound, with more and more critics concerned that the agency isn't tough enough when reviewing drug safety profiles, allowing drugs like Chantix and Vytorin to slip through the cracks.

FDA has no power to recall drugs today and has little authority to impose fines for safety violations. On their agenda is the replacement of the FDA commissioner, Andrew von Eschenbach, with someone who is less influenced by the industry.

- get the news from the Wall Street Journal
- here's more from SmartBrief
- read the Legal Times blog entry

Did FDA know Ranbaxy meds might be off?

Tracy Staton — Thu, 24 Jul 2008 10:55:08 -0400

Last week, amid all the brouhaha over the did-Ranbaxy-sell-substandard-meds probe, we reported that Congress had launched an investigation of its own--into just how the FDA handled those allegations once it found out about them. Well, according to a new letter sent to the agency commissioner by the seemingly insatiable investigatory duo of Rep. John Dingell and Rep. Bart Stupak, the agency knew about the accusations for 18 months. And, they say, FDA didn't take steps to pull the products off the market or even tell pharmacists about the suspected problems.

"If true, these statements would call into serious questions whether the leadership of the Agency... [has] met even the minimum requirements" of its mission to police the drug market. The Congressmen want Andrew von Eschenbach to respond to the letter within two weeks.

- see the story in the Wall Street Journal
- get more from ABC News

Pharma aims to forestall DTC legislation

Tracy Staton — Fri, 18 Jul 2008 09:37:54 -0400

Pharma industry lawyers descended on the U.S. capital this week to meet with House Energy and Commerce Committee staffers, hoping to forestall legislation that could limit drugmakers' ability to advertise their products, the Wall Street Journal Health Blog reports. As you know, that committee has been dogging pharma on its DTC advertising practices all year, and it staged a tough hearing on the subject in May.

So attorneys from PhRMA, the trade group, made the pilgrimage to counter some of the committee's proposals on DTC limitations. The association has been working on updating its voluntary guidelines--akin to the doc-gift-and-disclosure code announced last week--in hopes of forestalling legislation. Chairman John Dingell told the Health Blog that if PhRMA's new guidelines show a "serious effort to resolve the issues," then the committee will hold off on any more embarrassing hearings. But, he added, "The Committee... expect[s] results within a credible timeframe or we will be forced to consider whether a public airing would be a more productive way to proceed." Uh-oh.

- read the Health Blog post

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

FDA Commish chided over import safety

Wed, 23 Apr 2008 06:59:57 -0400

FDA Commissioner Andy von Eschenbach found himself in the hot seat again at a Congressional hearing. The House Committee on Energy and Commerce grilled the agency chief about foreign oversight and scolded him for safety lapses that occurred on his watch, including the big heparin debacle that's been unfolding since January. "You presided over this," Dingell said.

The committee wasn't happy with von Eschenbach's overhaul plan, either. And they didn't mince words about it. The GAO had appeared at the hearing earlier, estimating that it would cost $16 million to inspect only the Chinese exporters who hadn't yet seen FDA scrutiny, and $67 million to look at exporters worldwide. But when the commissioner skittered around the numbers himself, Dingell accused him of "toe dancing," saying, "I didn't fall off the cabbage wagon yesterday." (Even more colorfully, a Republican committee member from Texas said drug makers need to be held accountable for supply chain problems, "lest we get a bucket of chicken wings with plutonium in them.")

Dingell, you'll recall, released a draft plan for foreign oversight, and this hearing was supposed to gather fodder for the final bill he and his co-sponsors plan to enter. It looks as if the committee got some hard info from the GAO. It also got a few suggestions from von Eschenbach, namely, that FDA needs to hire contractors and/or depend on foreign regulators to certify foreign drug companies. And upon much pressing from Dingell, von Eschenbach coughed up some inspection figures for drugs: 3,000 facilities times $45,000 per, or $70 million on a biennial inspection schedule. How will this change Dingell's bill? We'll have to wait and see.

- see the Chicago Tribune story
- check out the New York Times article
- find a transcript of a few Dingell-von Eschenbach exchanges at In Vivo

FEATURE: Reading the tea leaves at the FDA

Tue, 22 Apr 2008 06:59:53 -0400

When lava flows from an island volcano--and when an extensive eruption is over with--the island will be re-shaped. Right now, that is what is happening on Capitol Hill. Members of Congress are reacting to long-standing inertia at the FDA by sending a multitude of rapid-fire letters and launching investigations into practices at the agency. Like the volcanic island, if we carefully examine the lava flow, we can get a pretty good idea as to how the regulatory landscape will change, what kind of reforms will be proposed through the election cycle, and what legislation will be sitting on the next President's desk. Here's what happened during the first quarter of 2008 in the areas that face the most change:

Changes in Fast Track/Accelerated Approval designations - In January, Senator Sherrod Brown (D-OH) has asked the Congressional Research Service, a research arm of the Library of Congress, to conduct an investigation of Fast Track at the FDA to see whether or not the practice of Fast Track is actually speeding the availability of drugs. On the other side of the aisle, Senator Chuck Grassley (R-IA) asks for an investigation by the General Accountability Office to investigate FDA's use of Accelerated Approval and the management of post-marketing commitments by companies. Pharmaceutical companies that don't know their own post-marketing commitment track record better prepare now to discuss it later at Congressional hearings.
DTC and Marketing Practices - Representative John Dingell (D-MI) has questioned the FDA role in supervising the Pfizer Lipitor ad campaign over the use of Dr. Robert Jarvik, who, though he is a doctor, has never practiced medicine. Then there was a call for the FDA to require drug makers to include a toll-free telephone number on ads so that patients can easily report adverse events experienced with drugs. Representatives Rosa DeLauro (D-CT)--who has referred to the management of the FDA as "Keystone Cops"--and Jan Schakowsky (D-IL) backed this legislation. Also on the House side, Congressmen Dingell and Stupak have written letters to Amgen and Johnson & Johnson seeking details regarding the marketing of ESAs. At the very least, look for reforms around DTC that address safety concerns and create greater transparency, or perhaps, as some have called for, a moratorium on advertising pending greater experience with a new drug.
Study Publication - The timing of the release of study results from the ENHANCE efficacy study on the combination drug Vytorin is the subject of another letter issued by Senator Charles Grassley sent to both Merck and to Schering Plough. Critics want to know why there was a delay between the time the results were known and the time they were released.

In addition to all this, the House Committee on Energy and Commerce Subcommittee on Oversight and Investigations is conducting six separate investigations of the FDA--on compensation, conflicts of interest, drug safety, device safety, food safety and into the Office of Regulatory Affairs. With so much going on, the climate is ripe for reform and a new FDA is taking shape now. - Mark Senak

Industry Voices: Reading the tea leaves at the FDA

Mon, 21 Apr 2008 15:14:45 -0400

Mark Senak is the author of the blog Eye On FDA

Changes in Fast Track/Accelerated Approval designations - In January, Senator Sherrod Brown (D-OH) has asked the Congressional Research Service, a research arm of the Library of Congress, to conduct an investigation of Fast Track at the FDA to see whether or not the practice of Fast Track is actually speeding the availability of drugs. On the other side of the aisle, Senator Chuck Grassley (R-IA) asks for an investigation by the General Accountability Office to investigate FDA's use of Accelerated Approval and the management of post-marketing commitments by companies. Pharmaceutical companies that don't know their own post-marketing commitment track record better prepare now to discuss it later at Congressional hearings.
DTC and Marketing Practices - Representative John Dingell (D-MI) has questioned the FDA role in supervising the Pfizer Lipitor ad campaign over the use of Dr. Robert Jarvik, who, though he is a doctor, has never practiced medicine. Then there was a call for the FDA to require drugmakers to include a toll-free telephone number on ads so that patients can easily report adverse events experienced with drugs. Representatives Rosa DeLauro (D-CT)--who has referred to the management of the FDA as "Keystone Cops"--and Jan Schakowsky (D-IL) backed this legislation. Also on the House side, Congressmen Dingell and Stupak have written letters to Amgen and Johnson & Johnson seeking details regarding the marketing of ESAs. At the very least, look for reforms around DTC that address safety concerns and create greater transparency, or perhaps, as some have called for, a moratorium on advertising pending greater experience with a new drug.
Study Publication - The timing of the release of study results from the ENHANCE efficacy study on the combination drug Vytorin is the subject of another letter issued by Senator Charles Grassley sent to both Merck and to Schering Plough. Critics want to know why there was a delay between the time the results were known and the time they were released.

Dems pitch big safety bill

Fri, 18 Apr 2008 06:59:57 -0400

It was inevitable: All the chit-chat about drug safety and the FDA's shortcomings had to result in legislation. Rep. John Dingell's House Energy and Commerce Committee released a "discussion draft" yesterday, planning to convene hearings over the next few weeks and draw up the real bill after that. Here's a primer:

Drug and device plants making products for the U.S. market would register annually with the FDA.
FDA would have to inspect all drug and device facilities every two years; no drug, ingredient, or device could be sold until its plant had been inspected at least once--and FDA approval could be yanked if this rule was violated.
Importers without documentation that they'd complied with all safety rules could only ship into ports with federal testing labs.
Drug and API makers would have to test their products for contaminants.
Drug labels would identify the source of active ingredients and specify where a drug was made.

The bill would give the FDA stronger enforcement powers, including the ability to recall drugs unilaterally and destroy counterfeit or contaminated imports. The agency would also be able to issue fines for violations.

And to pay for it all? Drug and device registrations would include new fees to cover the cost of inspections. That's sure to be a popular provision, don't you think?

- see the USA Today story
- check out the item at Pharmalot
- find the Associated Press article

ALSO: The Raleigh News & Observer sat down with FDA commish Andy von Eschenbach for a chat about overhauling the agency. Here's what he had to say. Report

Related Articles:
FDA wants satellite offices overseas. FDA report
Planning for the FDA's overhaul. FDA report
FDA pleas for funding gaining traction? Funding report
FDA chief admits need for funding, reform. FDA report

Pharma fighting back in Washington

Fri, 18 Apr 2008 06:59:56 -0400

Call it the backlash against the backlash. In the wake of the recent Vytorin and Vioxx marketing scandals, drugmakers are banding together to prevent a Congressional crackdown on their power to promote. Ten companies, including Pfizer, Bayer, AstraZeneca, and Johnson & Johnson, have formed a coalition to push for looser restrictions on off-label marketing, previously proposed by the FDA. Drug marketers also want to fight any proposed limits on DTC ads, including a new proposal to require the FDA's phone number in every ad. "We have to be concerned that Congress will act too quickly in this atmosphere," one marketing-strategy firm told the Wall Street Journal.

The Big Pharma coalition--which also includes the National Alliance on Mental Illness and the National Organization for Rare Disorders--will submit their arguments for new off-label promotion guidelines to the FDA today. You'll recall that the FDA wants to allow drugmakers to distribute journal articles that support unapproved uses for their drugs. Advocates say the practice educates physicians about new ways to treat difficult illnesses.

The atmosphere in the capital isn't altogether friendly, though. Several congressional investigations of drugmakers are underway, and Rep. John Dingell, chair of the House Committee on Energy and Commerce, plans to call hearings on DTC ads in a few weeks. "Drug companies should know that they will be held accountable," he said in a statement.

- read the WSJ article

ALSO: Two Harvard doctors are balking at the idea of banning any drugmakers' gifts to docs in Massachusetts; in a Boston Herald column, the physicians argue that the bill goes too far and would interrupt communication. One blogger notes, however, that the doctors misrepresent the provisions in the bill, and the WSJ points out that one of physicians is a director at Pfizer. Report | Report | Column

Related Articles:
Grand jury probes Vioxx marketing. Off-label report
Rep decries off-label marketing "loophole." Report
Ex-Pfizerite indicted in off-label case. Pfizer report
Should FDA's info be in all DTC ads? FDA report
Survey: No doubt DTC ads work. DTC report
Watchdogs circling DTC drug commercials. DTC report

Vytorin records created after the fact

Mon, 14 Apr 2008 06:59:58 -0400

Misleading minutes, swearing execs--just another day at the office for Vytorin's critics. Merck and Schering-Plough face new questions about their controversial Enhance trial as a Congressional committee releases documents that raise "serious concerns" about the companies' delay in reporting the results of that study, which showed that their high-priced combo drug Vytorin did no better at preventing artery-clogging than Zocor alone. The documents--unearthed by the committee in an ongoing probe of Enhance--show friction between Merck and Schering-Plough and questions about why the results weren't reported sooner. At one point, the tensions ran so high, a top Schering exec resorted to, shall we say, colorful language in an email.

But the most obvious question raised by the document dump is this: Why did the companies create minutes for a key meeting--in which experts and company execs discussed changing the study's primary endpoint--a month after the fact? Are those minutes inaccurate, as one participant in that meeting alleges? The minutes suggested that outside consultants recommended changing the endpoint--but James Stein, an imaging expert at the University of Wisconsin, said Merck and Schering-Plough made that choice. "We did not vote on this," Stein said in an email.

Meanwhile, some FDA documents have surfaced, showing just why Merck and Schering-Plough elected to pull Vytorin ads back in January. Apparently, the agency had been asking the joint venture to tone down the ads--which claimed superiority for Vytorin over statin therapy alone--at least since January 23. DTC promotions needed to be revised to show that "Vytorin has not been shown to provide any additional cardiovascular outcome benefits compared to using Zocor alone," the FDA letter said. Reps. John Dingell and Bart Stupak want to know what the company has done to comply--especially given that their deadline is April 24.

- see the M/S-P documents released by Congress (.pdf)
- read the story in Forbes
- see the Wall Street Journal article about the minutes
- check out the DTC item and FDA letters at Pharmalot

Related Articles:
Insurers, PBMs mull Vytorin data. Vytorin report
Congress: M/S-P sat on bad news. Report from Congress
Companies saw Vytorin threat in 2005. Vytorin report
Congress: Were Enhance results secret? Enhance report
Congress promises Vytorin hearings. Vytorin report
Merck, Schering's Vytorin fails trial. Vytorin report

Planning for the FDA's overhaul

Tue, 08 Apr 2008 06:59:58 -0400

Just about everybody agrees that the FDA needs a safety overhaul--including Commissioner Andrew von Eschenbach, who recently admitted the agency is in crisis. The agency itself drafted a five-year plan that would channel user fees into more safety evaluators, epidemiologists, regulatory project managers, and risk experts, all to beef up post-marketing drug-safety oversight. In addition to new staff, the plan calls for technology and communications systems, plus two or three years of intense staff training.

Meanwhile, Rep. John Dingell has been working on a plan of his own. According to Congressional Quarterly, Dingell would expand the FDA's regulatory authority by funding a team of full-time overseas inspectors. He'd require drugs, devices, and food products to be labeled according to country of origin. He'd levy new user fees to pay for spot checks at overseas plants and U.S. ports. Sweeping change is absolutely necessary, Dingell tells CQ, saying that the agency doesn't have "the vaguest idea who's producing these things, whether they're safe or not, whether they're using good manufacturing practices or not...or anything else that might relate to seeing to it that the safety of the American people is attended to." Ouch.

- read the Dingell item at Pharmalot
- see a summary of the FDA plan at FDANews
- check out the FDA's plan draft (.pdf)

ALSO: The San Jose Mercury News' editorial board says the FDA should be embarrassed by its lack of attention to the ingredients in prescription drugs--and that its laissez-faire foreign inspections make its refusal to import cheaper prescription meds (for "safety reasons") into "hypocrisy." Report

Related Articles:
FDA chief admits need for funding, reform. Report
FDA can't guarantee drug safety. Report
FDA wants satellite offices overseas. Report
FDA badly needs more money, staff. Report