Congress

Senator calls for outsourcing probe at FDA

Tracy Staton — Tue, 17 Jun 2008 09:54:45 -0400

A new senator is leaping into the pharma fray. Sen. Sherrod Brown, an Ohio Democrat, is calling on the FDA to evaluate its oversight of outsourcing practices. In a letter to the agency, Brown cites a statement by CDER Chief Janet Woodcock at a recent Congressional hearing, when she said some drugmakers outsource their operations because of "lower, less stringent standards in some parts of the world," in addition to lower labor costs. At the same hearing, a Pfizer exec said 17 percent of its active ingredient and drug manufacturing is outsourced--and Brown wants an explanation for that number, too. He wants to know not only how much Pfizer saves through outsourcing, but also what, exactly, has it outsourced to countries with "less stringent oversight?"

It had to happen: Outsourcing has been a hot-button issue, and a highly political one ever since Ross Perot's famous "giant sucking sound" quote when he was running for president. And this is an election year, after all.

- see Brown's release
- read the Pharmalot post

FDA might finally get its $275 mil

Tracy Staton — Tue, 10 Jun 2008 09:29:36 -0400

The FDA funding question has come full circle. First, the government's watchdog, the General Accounting Office, said FDA needed more money to do its job effectively. Then Congress asked FDA officials--repeatedly--to name a figure. A few months of that prodding finally yielded a number from Commissioner Andy von Eschenbach: $275 million.

Now, the Bush administration has seconded that figure, asking Congress to give FDA the money. HHS Secretary Michael Leavitt urged "Congress to act quickly to enhance the safety of food and medical products." With the added funds, FDA would open offices in China, India and Central America and hire another 490 people on top of the new employees it's already adding, bringing the total workforce expansion to 1,500, or 10 percent.

Apparently the big salmonella outbreak, linked to raw tomatoes, was the straw that broke the government's back. Coming on the heels of contaminated dog food, toothpaste, heparin, and more, the tainted tomatoes became one headline too many.

- read the New York Times story

Dems plan anti-preemption bill for devices

Tracy Staton — Thu, 05 Jun 2008 20:20:06 -0400

What the Supreme Court gives, Congress may take away. Democrats are planning to introduce legislation that would specify that FDA regulation doesn't shield device makers from state liability suits.

You'll recall that in February, the Supremes ruled that patients can't sue in state courts over FDA-approved medical devices. The high court said that the 1976 Medical Devices Amendment preempted patients' rights to sue in state court.

The justices are set to hear a preemption case involving drugs--a Wyeth drug, to be exact--this fall. And the debate over whether FDA approval should protect manufacturers from lawsuits is really heating up as that date approaches.

- read the Pharmalot post
- check out the Congress Daily story

FTC assails generic-delaying deals

Tracy Staton — Thu, 22 May 2008 10:55:36 -0400

The Federal Trade Commission is none too happy with Big Pharma's dealmaking with generics companies. Drugmakers are using legal settlements with copycat manufacturers to keep cheaper meds off the market, the FTC said, adding that what's good for companies in this instance is bad for consumers.

Over the 12 months ended September 30, almost half of the 33 agreements settling patent lawsuits included a restriction on the generic maker's ability to market a drug in return for compensation, the FTC's report said. The agency has sued to block some of these agreements and is supporting a bill in Congress that would ban them.

These sorts of deals have been on the rise over the past couple of years; there were three in fiscal 2005, 14 in 2006, and 14 last year. And the FTC has had only limited success in unraveling them: two appeals courts in 2005 upheld generic-delaying agreements made by Schering-Plough and AstraZeneca.

- see the FTC statement
- read the story in the Wall Street Journal
- check out Pharmalot's post

The FDA's surprising plea for cash

Wed, 14 May 2008 06:59:55 -0400

Finally, FDA chief Andrew von Eschenbach is crying uncle. After weeks of pressure from Congress to request more money for the agency--and weeks of refusals to specify a figure for beefing up FDA's safety operations--von Eschenbach has asked lawmakers for $275 million, posthaste.

The FDA chief made his plea in a letter to Sen. Arlen Specter that included a detailed plan for spending the money. Among the new expenses: opening new foreign offices, increasing inspections, and building new databases. No big surprises there. But the fact that von Eschenbach made the request--in writing, no less--surprised observers, because presidential appointees tend to toe the administration's budgetary line. Indeed, von Eschenbach himself seemed to be following that tradition, despite the best efforts of Congress to elicit a request for cash.

Not so anymore. "I never saw anything like this happen before," a former FDA commissioner told The New York Times.

- read the Times article

Could Clarinex be vulnerable to generics?

Wed, 30 Apr 2008 06:59:55 -0400

Consider this scenario from Fred Hassan's nightmares: The $800 million Clarinex, ostensibly under patent till 2020, falls early victim to generic competition. Early, as in next year. In court documents filed April 16, the Indian generics maker Orchid Chemicals alleges that Clarinex RediTabs was never covered by Schering-Plough's '274 patent. If that's so, then Orchid could launch its version of RediTabs almost immediately, the documents state. And so, apparently, could other copycat drugmakers circling the allergy med.

Schering disagrees with Orchid, of course. And though Orchid has some smart lawyers on the case, so does Schering-Plough. We'll have to wait and see what the court decides.

- check out the Pharmalot story
- see the item at Shearlings Got Plowed

ALSO: Drugmakers are lobbying Congress to change a particular patent rule that allows protection to be canceled if the patent holder misrepresented or concealed info in its application. Generics makers, however, say the penalty is necessary, because without it, branded drugmakers could "cheat and get away with it," making it more difficult for cheaper generic meds to make it to market. Report

SPOTLIGHT: AstraZeneca wants FDA ad review

Mon, 28 Apr 2008 06:59:52 -0400

AstraZeneca is lobbying Congress for FDA review of television ads. Last fall lawmakers created a program that would require up-front scrutiny of DTC ads, but didn't give the FDA authority to collect and spend industry fees to fund it. Report

Pharma drags feet on promised studies

Thu, 24 Apr 2008 06:59:55 -0400

We once saw a sign in a newsroom that said, "Deadlines, schmedlines, as long as I get paid." Maybe Big Pharma has similar signage posted at its various HQs. According to newly released FDA data, drug makers haven't even started more than 1,000 post-marketing studies they promised to do after their products were approved. And some of that research has been in the promised-but-not-started phase for years. Almost 450 have been on the pledge rolls since way back in 2004.

Now, some of that is the FDA's fault; the agency doesn't always set deadlines for this research. And some drug makers are doing their duties. About 16 percent of post-marketing research was on or ahead of schedule and 14 percent had been submitted to FDA or terminated before completion.

What we're wondering, though, is what FDA will do with its new powers to compel those studies, granted by Congress in the agency funding bill last fall. Will FDA start cracking the whip? Will drug makers shift these studies into high gear? We'll be watching the agency's numbers to find out.

- read the item at Pharmalot

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

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