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Posts Tagged ‘FDA’

The new guard at the Food and Drug Administration (FDA) has brought welcome, increased focus and action to protect people from unsafe or possibly unsafe foods. The most recent example is the massive recall recently of products containing hydrolyzed vegetable protein in which the FDA stated that although “no illnesses are known to be associated with this problem of [bacterial] contamination,” the agency was “taking steps to protect the public.”

Three cheers for that. New FDA Commissioner Peggy Hamburg and Principal Deputy Commissioner Joshua Sharfstein are rightly giving muscle to an agency that for too long has let industry call the shots.

However, in contrast to becoming more active in enhancing food safety by removing potentially dangerous products before they have caused harm, though, several FDA decisions in the past year regarding prescription drugs can only be described as reckless. (more…)

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We got a chuckle out of Henry I. Miller’s rant in Forbes today where he describes Public Citizen as “the rabidly antidrug, anti-industry, self-styled public-interest group.” The premise behind Miller’s commentary is that the Obama administration’s political appointments — and government regulation in general — are bad for business. Specifically, it’s getting harder and harder for the pharmaceutical industry to make a buck.

But excessive, erratic and highly risk-averse regulation has pushed development costs into the stratosphere, made approvals uncertain and slowed them to a trickle. As Fred Hassan, CEO of drug company Schering-Plough, said of the current regulatory climate: “What will it take to get new drugs approved? The point is, we don’t know.”

Miller

Excuse me while I wipe the foam from my mouth. Someone needs to clue these guys in on the fact that despite the “burden” of FDA regulation, the top pharmaceutical companies still rake in billions of dollars in profit each year. And while they complain about their research and development costs, the industry continues to spend almost twice as much money on marketing. Obviously, Miller and Hassan weren’t paying attention in 2009 when the FDA approved 26 new drugs, more than any of the previous four years.

But why should Miller, an anti-regulatory crusader and fellow at the conservative Hoover Institution, rely on facts when hyberbole will do?

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Four years ago, the Food and Drug Administration rejected Public Citizen’s petition to ban the weight-loss pill Meridia. At the time, the FDA said it wanted to wait to see the results of an ongoing trial. Well, those results are in and they show that Public Citizen’s concerns about Abbott Laboratories’ Meridia were well founded. Research from a 10,000-patient study shows that the popular weight-loss drug has caused a significantly increased number of heart attacks, strokes, resuscitated cardiac arrests and deaths in obese patients.

So, here we go again. Public Citizen filed another petition today asking the FDA for an immediate ban of Meridia. Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group, said the pressure is on the FDA to do the right thing:

If the FDA truly intends to operate as a public health agency, then it should acknowledge that the continued approval of this drug cannot be justified based on science. The FDA should therefore tell Abbott to pull Meridia from the market immediately.

When Public Citizen filed its first petition in 2002, it based its request on (more…)

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A few weeks ago, the Food and Drug Administration announced a new internal task force that would examine how the agency can become more transparent. The group would seek suggestions from employees, stakeholders and the public in an effort to reach the best conclusions about how the FDA could become more accessible. (For an overview of what the FDA does and does not regulate, see this Time article.)

Sure enough, the FDA has lived up to its promise. Today, Public Citizen’s own Dr. Peter Lurie, deputy director of our Health Research Group, is representing American consumers with testimony before the task force. While current FDA procedures favor secrecy so that drug companies can keep competitors in the dark about products being developed, Dr. Lurie will make three recommendations before the task force that will allow the FDA to become more open to the public.

First, Dr. Lurie will recommend that pre-approval documents should be made available to the public. This will prevent scientists from researching products similar to those that, unbeknownst to them, prior research has deemed unsafe, squandering time and money going down roads already proved to be dead ends. In addition, making this information public can save clinical trial participants from being put at needless risk by enrolling them in research likely to prove fruitless. (more…)

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Public Citizen has exciting news to share. This week, the U.S. Supreme Court in Wyeth v. Levine agreed with Public Citizen that patients harmed by defective and mislabeled drugs have the right to sue drug companies to recover compensation for their injuries.

This is a huge win not only for Public Citizen – who was part of the plaintiff’s legal team – but for all American citizens.

Drug companies aren’t perfect, and sometimes they fail to identify and inform doctors and the Food and Drug Administration (FDA) of problems with their products or their products’ labels.

And, most important, once a drug is marketed to thousands of people, we learn about things that we never knew in the clinical trials for that drug – problems that arise over the years as doctors prescribe and patients take the drug. (more…)

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wolfeThere’s a great piece in the Wall Street Journal today about Dr. Sidney Wolfe, the director of Public Citizen’s Health Research Group. Dr. Wolfe, who over the years has worked to get several harmful drugs off the market and stricter warnings put on other drugs, was recently appointed to a four-year term on the Food and Drug Administration’s Drug Safety and Risk Management Committee, which advises the FDA on the safety of drugs. WSJ reporter Alicia Mundy’s lead in her story, “A Wolfe in Regulator’s Clothing: Drug Industry Critic Joins the FDA” is wonderful:

The pharmaceutical industry has a recurring nightmare: Drug-safety crusader Sidney Wolfe becomes a player at the Food and Drug Administration.

Dr. Wolfe also has a nightmare: One of his children goes to work for a drug maker.

Of the two, the doctor is sleeping more soundly.

Mundy also videotaped an interview with Dr. Wolfe. To learn more about dangers and side effects of the drugs you take, visit the Public Citizen resource: Worst Pills, Best Pills.

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The Washington Post reports that the FDA has started “blocking” milk products from China — if they test the product and find that it’s not tainted with melamine, then it can be sold in U.S. stores.

Why does this not make me feel very secure?  Why are we’re importing milk products in the first place?

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flickr photo / macwagen

We’ve heard for a while that politics trumps science for this administration. But today, proof emerged that it’s true.

The House Oversight and Government Reform Committee (thank you, Rep. Henry Waxman) issued a report showing that the Bush administration has pulled out the stops to shield drug companies from liability for dangerous drugs, leaving patients out in the cold. Here we have clear documentation of how the White House hijacked an agency and forced it to undermine its own mission. (more…)

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flickr photo/mrjoro

Public Citizen won another victory against pre-emption in the case of a New Jersey woman who sued Chicken-of-the-Sea after suffering severe mercury poisoning from eating canned tuna. Chicken-of-the-Sea and the FDA tried to argue that the woman’s case should be thrown out because the FDA had issued an advisory brochure warning of canned tuna’s potentially hazardous heavy-metal content. (more…)

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Photo by Bridgette Blair

Taking a mislabeled drug or using a defective medical device is a dangerous thing. Just ask actor Dennis Quaid and his wife, Kimberly.

In November 2007, their newborn twins were given a massive overdose of Heparin, an anticoagulant drug. The twins were supposed to receive another drug that would ease the intravenous administration of antibiotics. Why were they given the wrong medication? The two drugs’ labels were similar. Baxter Healthcare Corp., the manufacturer of both drugs, was aware of the problem – in 2006, the same confusion over the labeling of Heparin caused the death of three infants at an Indianapolis hospital. Baxter relabeled Heparin to avoid this confusion before the Quaid twins were born. But here’s the shocker: The company didn’t recall the drug stock with the confusing label, so it remained on pharmacy shelves and was eventually injected into the twins.

The twins survived, barely.

Dennis Quaid made his way to the Hill this morning to tell his and his wife’s story at a Congressional hearing, and Public Citizen attorney Brian Wolfman accompanied them as part of their legal counsel. (Wolfman, director of the Public Citizen Litigation Group and a preemption expert, has written an article about preemption and why its proponents are wrong in TRIAL Magazine.) (more…)

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