legislation

States: Say no to pre-emption

Tracy Staton — Fri, 15 Aug 2008 09:22:34 -0400

Forty-seven states are weighing in on the legal battle over pre-emption--and predictably enough, they're against it. The pre-emption doctrine would, of course, enshrine FDA approval as the be-all and end-all of drug safety. If the agency has blessed a drug for sale, then drugmakers are covered; nobody could sue drugmakers for damages in state court. Or so the reasoning goes.

The states aren't convinced. They're asking the U.S. Supreme Court to uphold a Vermont ruling in Wyeth v. Levine, the case of a professional musician whose arm had to be amputated after she was injected with one of the drugmaker's products. The musician was awarded $6.8 million in damages, and Vermont's high court wasn't convinced by Wyeth's argument that FDA approval should shield it from liability.

Now, the U.S. Supremes are set to hear the case in November, and various parties are lining up on either side of the case. The federal government supports pre-emption. Trial lawyers are fighting it. It will be closely watched: If the Court blesses pre-emption, drug suits across the country could be tossed.

As you know, the Court sided with device makers on pre-emption this spring, but devices are governed by different law, so there's no guarantee that it will do the same in the Wyeth case. Plus, Congress quickly started working to revamp the device law to protect the people's right to sue.

- read the story in the Boston Globe

Comparative effectiveness bill hits Senate

Tracy Staton — Thu, 07 Aug 2008 11:05:11 -0400

How do different antidepressants stack up? Blood-pressure meds? Diabetes drugs? Do we know? Well, Sen. Max Baucus says he aims to find out: He's introduced a bill that would create an institute for comparative-effectiveness research. The not-for-profit would operate separately from the government, but would include reps from Health and Human Services, National Institutes of Health, and the Agency for Healthcare Research and Quality--plus drug and device makers, patients, and doctors.

The institute would be funded by public and private payers--a.k.a. Medicare and insurance companies. “Doctors and patients need reliable, unbiased information about the effectiveness of treatments to determine the best care possible," Baucus said in a statment, "but right now that data is scarce and unorganized."

Not everyone is sold on the comparative effectiveness idea. Some fear that it would end up going the way of the U.K.'s National Institute for Health and Clinical Excellence--which, though well respected, does get into hot water from time to time for rejecting treatments based on cost. We'll see who prevails.

- read the press release
- see the post at Pharmalot

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

Doc disclosure gets boost from AZ, Merck

Tracy Staton — Fri, 23 May 2008 09:58:51 -0400

Drugmakers are climbing on the disclosure bandwagon. AstraZeneca and Merck have come out in favor of a bill requiring pharma and device-makers to report their payments to doctors, joining Eli Lilly, which gave the legislation a thumbs-up last week. Trade associations PhRMA (drugs) and Advamed (devices) have also expressed support.

The outpouring of support began after the bill's sponsors--Sen. Chuck Grassley and Sen. Herb Kohl--bumped up the minimum disclosure amount to $500 from $25. It also helped that they added language specifically preempting state disclosure rules--now in force in Vermont and Minnesota, and on the drawing board elsewhere.

Interestingly, Schering-Plough isn't among those backing the bill. In fact, the company expressly denied its support in a letter to the sponsors. The reason? That information might undermine the relationship between patients and doctors, the company says. We'll see if it changes its tune: The letter said execs "remain open to new information or points of view."

- check out the release from the Senate Special Committee on Aging
- read the item at the WSJ Health Blog
- see Pharmalot's take

FDA backpedals on inspection funding

Fri, 02 May 2008 06:59:58 -0400

Now you see it, now you don't. Congress thought--or pretended to think, you never know on Capitol Hill--that the FDA had ball-parked the funding it needs to beef up foreign inspections. That would be $225 million, a number contributed by CDER chief Janet Woodcock on Wednesday. But Thursday at a hearing of the House Energy and Commerce Committee, Woodcock backed away from that figure, saying that the agency does need more resources, but the Bush administration had to say how much.

Woodcock also declined to support the lawmakers' proposed legislation, which would boost inspections and enforcement powers in an attempt to prevent contaminated drugs from slipping into the U.S. Mandating foreign facility inspections every two years isn't a good idea, she added, saying that the FDA should decide which plants to check out, based on risk assessment.

Neither would Woodcock support user fees as a funding mechanism for inspections. But industry types who testified at the same hearing said they're open to those fees--within limits. And the industry wants assurances that inspections will focus on "high-risk" foreign manufacturers.

Consumer advocates are also OK with user fees, but also within limits. Drugmakers shouldn't use the fees as a way to "exert undue influence over FDA," Consumers Union said. Some advocates say the industry already has too much sway over the agency because of user fees that finance the approval process.

- see the user-fee article in the Star-Ledger
- read the Wall Street Journal story

Bill to propose federal drug comparisons

Wed, 02 Apr 2008 07:59:57 -0400

Should the feds fund studies to compare drugs' effectiveness? The idea appears to be gaining traction. Two congressmen are readying legislation that would create an institute to systematically examine drugs and devices.

It's a controversial idea: Drug and device makers are naturally worried, but so are anti-big government types who fear that a British-style drug review board would interfere with consumer choice, physician autonomy, and market dynamics. But on the pro side of the ledger are some economists and business groups who think that this sort of research could cut healthcare spending by hundreds of billions annually.

- read the item at Pharmalot

Related Articles:
Pact adds cost effectiveness to drug study. Report
Where's the ROI on drug R&D budgets? Report

Could full data disclosure avert scandal?

Mon, 24 Mar 2008 07:59:58 -0400

New calls for old drug data in the U.K. have experts second-guessing big drug-safety scandals. If scientists and regulators had had access to every bit of data on Vioxx from the get-go, for instance, would heart attacks and strokes have been averted? Ditto Avandia? "People might have realized that the claims being made for the drug were overblown and coy to the point of being fraudulent," one expert told the Associated Press.

These questions are arising in the wake of a British investigation into GlaxoSmithKline and its antidepressant Seroxat. The government concluded that GSK withheld information on the med's suicide risk for teens, but could not prosecute because withholding that data wasn't illegal under British law because Seroxat wasn't approved for use in kids, just adults. (GSK maintains that it didn't withhold info, anyway.) Officials say they intend to strengthen legislation governing clinical trial info by year's end.

The worry is that safety risks aren't being reported by drugmakers until they absolutely have to. "It would be unwise to assume that this particular case was anomalous," a journal editor said. But other observers emphasized the fact that some side effects aren't known until a drug hits the market and is administered to millions of people instead of a few thousand as in a clinical trial.

- read the story in the International Herald Tribune

Related Articles:
UK patients sue for Paxil withdrawal. Report
Study highlights link between Paxil and suicide. Report
Top 10 Drug Warnings and Recalls of 2007. Report

Agencies take aim at patent settlements

Wed, 20 Feb 2008 06:59:57 -0500

Are quid pro quo deals between brand-name drug makers and generics firms in real danger? Euro watchdogs are scrutinizing them, the FTC is suing over them, and the U.S. Congress is considering an outright ban on them.

Perhaps that's because Big Pharma has been cutting deals with generics makers right and left. There's the big Cephalon arrangement that's attracted the FTC's ire: That company paid Teva, Barr, Ranbaxy, and Mylan a total of $200 million to say out of the Provigil market until 2012. The FTC counts 100 deals like this since 2004.

The FTC hasn't had much success in the courts so far, but it's hoping for a grand slam in the Cephalon case. The agency would like the issue to go to the Supreme Court so it can be resolved "once and for all." There's no guarantee, though, that the newly conservative court would rule against these deals. The government's best shot may be in Congress. A Senate committee last week approved a bipartisan bill that would prohibit these arrangements; similar legislation is pending in the House.

Meanwhile, the generics market isn't growing at quite the pace it once was. According to preliminary figures from IMS Health, sales increased by 3.8 percent last year--the same rate as the overall drug market. The market research firm was surprised by those results: "I checked this number and checked it twice," an IMS rep told In Vivo. "We have seen generics growing over the last couple of years somewhere between 10 percent and 20 percent. So to come in...at 3.8 percent is quite dramatic."

- read the Fortune article
- check out the market figures at In Vivo

Related Articles:
FTC sues Cephalon for blocking generics. Report
AstraZeneca, Par collaborate on authorized generic. Report
Wyeth makes its own Protonix copy. Report
Analysts get bullish on generics makers. Report

Pharma faces payment disclosure law

Fri, 07 Sep 2007 06:59:58 -0400

Senator Charles Grassley said he would, and now he has: The Republican introduced a bill Thursday that would require drug and medical device makers to report almost every cent they pay to doctors. Each payment of more than $25 would have to be disclosed quarterly, and the data would be posted on a government website.

For several months now, news reports and Congressional hearings have been questioning the flow of dollars from drug makers to doctors--everything from free meals to speaking fees to consulting payments. Some doctors have reaped hundreds of thousands a year in such gifts or fees-for-services. The natural follow-up question--does it change doctors' behavior when they pick up their prescription pads?--has prompted much defensive denial, but it's also inspired fears of unnecessarily costly scrips and even patient harm.

Anticipating the outcry from pharma, Sen. Herb Kohl, the bill's co-sponsor, said that if companies have nothing to hide, then disclosure will only vindicate them. "Either way, patients win," he said.

- check out the release
- read the New York Times article

ALSO: Should drug and medical device makers be made to to report payments made to doctors? Poll

Related Articles:
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Doctors weigh in on pros, cons of accepting freebies. Letters
States tighten screws on pharma marketers. Report