FDA

11 Jul: China beheads ex-chief of its FDA

Forget Michael Moore and Cuba; now even China seems to have a few healthcare tricks we could learn from. Here’s the story from MSNBC: China on Tuesday executed the former head of its food and drug watchdog who had become a symbol of the country’s wide-ranging problems on product safety. Zheng Xiaoyu’s execution was confirmed by State Food and Drug Administration spokeswoman Yan Jianyang at a news conference held to highlight efforts to improve China’s track record on food and drug safety. Such cases “have brought shame to our administration and revealed serious problems. We need to seriously reflect on what lessons we can draw from such cases,” Yan said about Zheng and a separate case involving Cao Wenzhuang, the…

05 Jul: Dr. Free-Ride on Generation Rx

Over at the Adventures in Ethics and Science Blog, Janet Stemwedel (aka, Dr. Free-Ride) has an interesting piece on Greg Critser’s Generation Rx , a book I’ve been meaning to read for some time. I think, with Janet’s inspiration, now I will. Summarizes Janet: Critser starts off by dropping us into the regulatory environment in the U.S. in the early 1970s, walking us through the multifarious forces that started to change that environment. Some of the changes seem welcome and important — for example, removing the requirement that companies wishing to market generic versions of FDA approved drugs … produce additional studies demonstrating the compounds to be safe and effective rather than being able to point to the existing studies…

17 Jun: Zimulti: An obesity drug to die for?

From Bloomberg: Sanofi-Aventis SA shares had their biggest drop in three years, wiping out more than $7 billion in market value, after a U.S. panel blocked the company’s new weight-loss pill because it was linked to suicides. Says Derek Lowe: Everyone will have heard the news about Wednesday’s FDA Advisory Commitee vote on Accomplia / Zimulti (rimonabant). If you’d tried to convince folks a few years ago that this drug wouldn’t make it to a vote until summer of 2007, and would be unanimously rejected when it did, you’d have been looked at with pity and concern. No, this drug was going to conquer the world, and now people are talking merger-of-desperation. By the way: FDA approval of Zimulti was…

17 Jun: FDA’s biggest concern should be consumers health, not of Big Pharma

Conflict of interest is a major theme on our blog. When a person is on trial, friends and family are not allowed on the jury because they would have biased judgment. When someone has interest in the outcome, it is virtually impossible to expect a fair decision. Such has been the case with the FDA, particularly in recent years. Now, a bill that would reform the FDA is before the House. The proposed legislation includes language that would limit FDA advisory committees to only one scientist with a conflict of interest per meeting. That may sound like one too many — but in the world of the FDA, that would be real progress. According to Merrill Goozner, Currently, nearly a…

11 Jun: FDA: Big Pharma’s little buddy

Gardiner Harris writes in the New York Times: A series of drug-safety scandals has led many on Capitol Hill to question whether the Food and Drug Administration has failed to strike the right balance between speed and safety. A clear sign of this imbalance, these critics say, is the increasing number of F.D.A. drug-safety officers who say they have been punished or ignored after uncovering dangers of popular medicines. The problem is not only the FDA rubber-stamping drugs for the market, but also leaving unsafe products on the market after they are found to be dangerous. Isn’t it time we stood up and demanded that our regulators be independent of the companies they are regulating?

08 Jun: Advertisers say new drug bill would restrict commercial speech

Broadcasting companies and advertisers (the two interested parties with the most revenue to lose) are vigorously fighting the new drug safety bill before Congress. According to Broadcasting & Cable: the Advertising Coalition said they want [John Dingle D-Mich] to oppose parts of the Enhancing Drug Safety and innovation Act of 2007 (H.R. 1561), that would include a three-year waiting period before ads could air for new medications, preclearance of ads by the FDA, and mandated warnings. The Advertising Coalition, which includes advertising groups, the National Association of Broadcasters, the National Cable & Telecommunications Association, and the National Newspaper Association, claims that the bill is unconstitutional, and offered up a monetary penalty system for false advertising in its stead. Obviously, a…

08 Jun: The FDA’s eight-year plan for testing Avandia

Here’s the story. Drug companies are going to try to get away with everything they can to make a profit, that’s a given. The FDA should be the regulatory force that keeps Big Pharma in check instead of being its accomplice. As long as the FDA is getting its paycheck from Big Pharma, drugs are going to keep getting approved, and American citizens will continue to be stuck in the middle … getting screwed. Henry Waxman summed it up well when he said, Despite additional warnings from outside experts, despite the millions of patients who rely on Avandia to control their blood sugar, and despite the potential risks involved, FDA never required the manufacturer to conduct a thorough postmarket study…

24 May: This is why the FDA allows unsafe drugs on the market

Marilynn Marchione from the Associated Press asked a good question in her article today: How does a drug go from blockbuster to bust? How can big safety issues go undetected in medicines taken by millions of people for many years, as happened this week with the diabetes pill Avandia and a few years ago with the painkiller Vioxx? Here’s a three-letter hint: the FDA. As long as the FDA has a vested financial interest in helping drug companies bring product to market, we will see these scenarios for years to come. Isn’t it ironic that the FDA won’t allow the importation of drugs from Canadian pharmacies due to “safety reasons,” but will allow a drug to stay on the market…

07 May: There is still time to stop FDA, Inc.

So says Byron Richards of Truth in Wellness: Last year’s Institute of Medicine report labeled FDA management as dysfunctional causing FDA reform to pick up momentum. To deflect public outrage, [bill] S1082 was created … in close consultation with the FDA and Big Pharma. As you might expect from such a meeting of the minds, the bill is really a Big Pharma-sponsored con job… Bill S1082 is a bill that helps fund the FDA with Big Pharma money… Richards analyzes the potential legislation’s effect bluntly: It is hard for anyone to comprehend that the agency that is supposed to be in charge of drug safety is about to become a drug company. It is astonishing that the FDA will now…

23 Apr: When it comes to drug ads, is the FDA the new MPAA?

I find the FDA’s new plan to have pharmaceutical companies directly fund the agency’s review of drug commercials — through so-called “user fees” — strangely amusing. But then, I always found Orwell amusing, too. The FDA positions the plan as a toughening of previously lax regulations in response to public complaints about direct-to-consumer ads. The reality is, the projected $6 million in annual fees for FDA review would primarily serve to keep the drug ads coming at a blistering pace. As one observer sums up FDA priorities: [FDA officials] behave as if their job is to get as many “good products” to the American public as quickly as they can. The focus should be on public safety rather than on…

06 Apr: Sally Field pimps Boniva — oh, I mean “Bone Health”

Apparently, it isn’t enough for Sally Field to do commercials for Boniva — now she’s pimping it on Martha Stewart’s show. John Mack found this description on an online forum: Sally Field was on [Stewart’s] show today and mentioned that she has osteoporosis and wanted to talk about Bone Health … Sally mentioned medications, and said she takes the once-a-month Boniva. Martha interrupted her to ask if it’s full of vitamins and minerals. Sally said, “No, it’s a treatment.” Martha said, “Reeeally, no minerals?” WTF? Then Sally finally said she wanted to talk about Bone Health again, and again, Martha cut her off for a commercial break … One more segment, Sally has twice said, “I wanna talk about Bone…

22 Mar: FDA passes rule to limit Big Pharma control over agency advisers

From the New York Times: Expert advisers to the government who receive money from a drug or device maker would be barred for the first time from voting on whether to approve that company’s products under new rules announced Wednesday for the F.D.A.’s powerful advisory committees. Indeed, such doctors who receive more than $50,000 from a company or a competitor whose product is being discussed would no longer be allowed to serve on the committees, though those who receive less than that amount in the prior year can join a committee and participate in its discussions. A “significant number” of the agency’s present advisers would be affected by the new policy, said the F.D.A. acting deputy commissioner, Randall W. Lutter,…

19 Feb: FDA still trying to scare people away from online pharmacies

From iTWire: The US Food and Drug Administration (FDA) has issued a warning to consumers about placing orders for prescription drugs over the Internet, saying that recent cases have shown that what was delivered is not what was ordered and is putting people in hospital. In a release, the FDA said it has become aware that a number of Americans who placed orders for specific drug products over the Internet (Ambien, Xanax, Lexapro, and Ativan), instead received a product that, according to preliminary analysis, contains haloperidol, a powerful anti-psychotic drug… The FDA said laboratory analysis of the misrepresented tablets is ongoing, but preliminary analysis indicates they contain haloperidol, the active ingredient in a prescription drug used primarily to treat schizophrenia….

05 Feb: Five Questions with Merrill Goozner

Merrill Goozner is one of our heroes. In fact, his 2004 book, The $800 Million Pill, was one of our inspirations for starting eDrugSearch.com. Obviously, ours is a for-profit venture — but we also think we are doing some good by offering consumers an alternative to Big Pharma’s rigged pricing system in the U.S. We recently asked Merrill about his interest in the pharmaceutical industry, his opinion on Canadian imports, and his predictions for the future of our healthcare system. Cary: You’ve covered many, many stories over the course of your career in journalism. What is it about the pharmaceutical industry that has captured and held your interest? Merrill: While attending the Breaux-Thomas commission hearings on Medicare reform on Capitol Hill…

19 Dec: FDA can’t keep up with Big Pharma advertising claims

I guess Big Pharma’s advertising is getting a little out of hand. According to MedsAbroad.com, a recent GAO (General Accountability Office) report stated, The FDA Division of Drug Marketing, Advertising, and Communications (DDMAC) [said] a bottleneck … had formed when the DDMAC was told by Health and Human Services (HHS – the authority which oversees the FDA) in 2002 that they needed to have all the regulatory letters to drug companies reviewed and approved by the FDA Office of the Chief Counsel (OCC) before they issued. These letters are used to tell the drug companies that their direct-to-consumer (DTC) advertisements are in violation of regulations. According to figures in the report, DTC advertising has increased 20 percent a year from…

15 Dec: Who’s afraid of the big, bad Congress?

The Kaiser Network reports: The Raleigh News & Observer on Wednesday examined how the expected congressional approval in 2007 of a bill that would renew the FDA Prescription Drug User Fee Act has “pharmaceutical and biotech executives worried” over unrelated provisions that Democrats might attach to the legislation. According to the News & Observer, Democrats, who will take control of Congress in January 2007, might attach to the bill “price controls under Medicare, more safety assessments, provisions that would open the debate on stem cell research and requirements to publish all late-stage drug-testing results.” Marc Scheineson, an attorney who represents pharmaceutical companies, said that the bill “could become a Christmas tree with lots of ornaments.” Pharmaceutical companies “are turning to…

09 Dec: Drug-coated stents ruled safe by FDA advisory panel

DrugWonks reports that an FDA advisory panel has ruled controversial drug-coated heart stents to be safe. The ruling comes despite research that shows blood clotting is four to five times more likely to occur in patients who have the stents. We’re sure the decision is entirely unrelated to the fact that six of the panel members were found to have financial ties to companies that produce stents. More info here and here. Can anyone say Vioxx?

08 Dec: Senator-elect Sherrod Brown: First we go after Big Pharma

From a Mother Jones interview with Ohio senator-elect Sherrod Brown: MJ: What do you want to do on the Health and Education Committee? SB: FDA reform wrestling the agency away from drug company influence. In my 14 years in the House, I’ve seen a very good agency, the Food and Drug administration one of the best public agencies in the world, frankly turn into a shadow of itself because of drug company influence. I think the best way to fill the donut hole [the coverage gap in the Medicare drug benefit] is to negotiate drug prices. When you negotiate drug prices on behalf of 40 plus million beneficiaries, the donut hole begins to shrink.

06 Dec: Torcetrapib’s failure is no excuse for overpriced drugs

As expected, Pfizer’s failed attempt to bring torcetrapib to market has led the pharmaceutical industry to argue that overpriced drugs are necessary to lessen the blow of R&D setbacks. However, at Pharma Marketing Blog, John Mack says the reported $800 million in R&D for torcetrapib is probably inflated: If Pfizer really spent $800 million on the 15,000-patient torcetrapib trial, that would mean that it spent $53,000 per patient! Even at $10K per patient for a trial–two to three times a typical CRO estimate and 50 percent higher than the NCI’s reported average costs–a 15,000 patient trial would cost about $150 million, not $800 million. Granted, there were probably other trials, but this was the biggest by far. Even doubling the…

04 Dec: When it comes to healthcare in U.S., the question is, “Who benefits?”

From the Daily Kos: When it comes to healthcare in America, the first question you should frequently ask yourself is: Cui Bono–who benefits? There is an unholy alliance between the FDA, which is supposed to protect us, and the medical device and pharmaceutical industries. Indeed, there is growing evidence, that your safety and mine has taken a back seat–or more aptly, no seat–to the thoroughly politicized agency… Let’s take a quick look at the connection between big pharma and kidney dialysis patients. The Food and Drug Administration yesterday warned doctors not to excessively boost patients’ red blood cell counts with anti anemia drugs, following publication of a clinical trial this week that found exceeding the FDA’s dosing recommendations increased the…

04 Dec: What’s good for Big Pharma is good for the U.S.? Hardly

If you want to read something that will make you sick, try this column in the Boston Globe, “What’s good for pharma is good for America.” The author, an academic named Richard Epstein, has experience as a Big Pharma consultant (although this is only mentioned at the end of the piece.) The headline reminds of us of an equally wrong-headed statement many years ago by the CEO of General Motors: “What’s good for General Motors is good for the country.” Of course, if our country had tied our wagon to GM, we’d be in real trouble these days. GM has had to compete in a world market, and Big Pharma should have to compete as well — instead of being…

22 Nov: FDA figures out another way to make you pay more for drugs

From Reuters: The U.S. Food and Drug Administration has struck a deal with pharmaceutical companies under which they would pay the agency fees for vetting their TV advertisements in exchange for speedier reviews… The FDA is expected to get more than $300 million in user fees in fiscal 2007, the last year of the current arrangement. The figure would increase by about one-third in fiscal 2008 under the proposed agreement… Let us break this down for you: The FDA is charging Big Pharma more to approve TV commercials faster, so drug companies can put more ads on TV faster. Big Pharma will then pass these costs — as well as the costs of the additional commercials they will presumably now…

17 Nov: When it comes to safety, it’s all about the pharmacy

In the fight to legalize the purchase of prescription medications from licensed Canada pharmacies, the FDA’s primary argument against importation is safety.  But the reality is, the risk of purchasing unsafe drugs is no greater in Canada than the U.S. Let’s say you buy a car stereo from the trunk of someone’s car; you are at higher risk of receiving a bogus product than if you purchased a stereo from an electronics retailer like Best Buy.  The same is true for prescription drugs; if you buy from an unreputable pharmacy, you run the risk of receiving poor quality or counterfeit medication. Did you know that the U.S. government is the number-one importer of prescription medication from Canada? The U.S. government…

16 Nov: Why do prescription drugs cost so much more in the U.S. than Canada?

The price gap between American and Canadian drugs continues to grow at a record pace. But what is causing the price of Canadian medications to remain stable while the price of American medications skyrockets? There are two primary reasons: 1.) Drug Price Controls In Canada, a government review board places a maximum market price for all new brand name drugs entering the market, and allows prices to rise only at the rate of inflation. These controls protect the consumer from price gouging by the major pharmaceutical companies and reduce the price difference between brand name and generic drugs. 2.) U.S. Consumers Bear the Entire Burden of R&D — and More American consumers pay roughly 3000 percent more than the actual…

15 Nov: Why the ban on Canadian drug imports is not enforced on individuals

The push to legalize Canadian drug importation has been a dominant headline in the newspapers over the last several years.  Stories of how the elderly load up on buses and go north to save money are heard all too often.  But are those seniors actually criminals for purchasing their medications in Canada? If the government wanted to, it could throw grandma and grandpa behind bars for illegally importing prescription medications.  This doesn’t mean that the government is going to prosecute the average Joe trying to save money on his prescription drugs.  The government is more worried about companies purchasing large amounts with the intent of reselling them in order to make a profit. Although the FDA does not encourage importation,…

13 Nov: Why the FDA is against Canadian imports — separating myth from reality

The FDA was created to serve the American public by assuring that our food and drugs are safe.  In recent decades, however, the FDA has focused less on public health and more on protecting drug-company profits.  That’s the real reason the Bush Administration and the FDA oppose medication imports from Canada.  Let’s look at some of the arguments against Canadian imports and compare them to the realities: 1.) Loss of Jobs The Bush Administration claims that legal Canadian imports will cause a loss of jobs in the pharmaceutical industry.  The reality is that allowing drug imports — like other forms of free trade — will simply create a more competitive market, yielding lower prices that will put money back into…

08 Nov: Municipalities increasingly importing Canadian drugs for employees

Earlier this year, Boston joined the growing number of cities that have turned to Canada in search of more affordable prescription medications. Mayor Thomas M. Menino implemented a plan that is expected to save the city of Boston over $1 million over the next year by importing prescription medications for city workers and retirees. City council member, Felix Arroyo blamed the rapidly rising cost of drugs on the big pharmaceutical companies. “We need a limit to profits when our lives are on the line,” he said. Many other cities have already taken the same steps to order their prescription drugs from licensed Canadian pharmacies to cut back on costs.  Springfield, Mass., was the first city in the nation to implement…