Tag: "FDA"

FDA Has a Good Idea; Doctors Object

The idea: In a move that could help the government trim its burgeoning health care costs, the Food and Drug Administration may soon permit Americans to obtain some drugs used to treat conditions such as high blood pressure and diabetes without obtaining a prescription.

The Doctors’ Objection: “What the government via the FDA has decided to do is just bypass the expensive doctor and to satisfy some safety concerns of letting people just pick out their medications is make sure they have to get counsel by the pharmacists,” Dr. Mintz [an internist at George Washington University Hospital] said. “I believe there is value to using pharmacists, but not at the expense of primary care.”

The Pharmacists Counter: “We think it’s a great development for everybody — for pharmacists, for patients and the whole health care system,” said Brian Gallagher, a lobbyist for the American Pharmacists Association. “The way we look at it is there are a lot of people out there with chronic conditions that are undertreated and this would enable the pharmacists to redirect these undertreated people back into the health care system.”

More from Paige Winfield Cunningham in the Washington Times.

May 03, 2012 | 5 comments | by

A Better Way to Approve Drugs

In this paper, Avik Roy examined drug development in four major public health areas and discovered that for any given drug on the market, typically 90 percent or more of that drug’s development costs are incurred in Phase III trials. The current Phase III trial system forces pharmaceutical and biotechnology companies to take enormous financial risks and burdens them with needless and unpredictable regulatory delays. It prevents start-up biotech companies from challenging the dominance of large, multinational pharmaceutical concerns. It also, perversely, encourages more innovation in drugs for very rare diseases than it does in drugs for common conditions that afflict hundreds of millions of Americans.

Roy recommends allowing drugs that have been found safe and promising (in Phase I and Phase II clinical trials) to win approval for limited marketing to patients. This would give patients early access to innovative new therapies, while the FDA would retain the ability to collect information confirming the drugs’ safety and effectiveness and to revoke a drug’s marketing authorization later, when appropriate.

May 01, 2012 | 3 comments | by

So This Is How the F.D.A. Makes Decisions

In the F.D.A.’s view, the law called for moviegoers to know that many a buttery bucket of popcorn had more calories than two Big Macs, but Ms. DeParle, President Obama‘s chief health adviser, thought the requirement was unnecessary and would probably be lampooned on Fox News as an especially silly example of the government intrusions that conservatives often mocked as the nanny state.

Dr. Margaret A. Hamburg, the F.D.A. commissioner appointed by Mr. Obama, soon heard about the White House’s displeasure and called Ms. DeParle at home one evening, people with knowledge of the call confirmed. The women had a decidedly chilly conversation. Within days, the F.D.A., an agency charged with protecting public health, backed down and dropped the notion of calorie counts for foods served in movie theaters and on airplanes.

More from Gardiner Harris in The New York Times.

Apr 04, 2012 | 6 comments | by

Is Salt a Public Health Danger?

Last year, the government’s Institute of Medicine urged the Food and Drug Administration to “gradually step down the maximum amount of salt that can be added to foods, beverages and meals.” The FDA is listening. In September, it published a notice concerning issues “associated with the development of targets for sodium reduction in foods to promote reduction of excess sodium intake.”

[Yet] “For every study that suggests that salt is unhealthy, another does not,” an article this year in Scientific American noted.

Full article by Steve Chapman on salt consumption regulation. See our previous posts here, here and here.

Dec 29, 2011 | 4 comments | by

Why Are There Drug Shortages?

Regulations: In 2010, product quality issues — and the subsequent regulatory actions taken by FDA to address these problems – were involved in 42% of the drug shortages.

Price controls: The result of these policies is that generic prices can’t rise to reflect changing demand or the need for bigger investments in manufacturing.

Labeling restrictions: that prevent firms from branding their products, and reflecting by how they price them, legitimate improvements in manufacturing that allow drugs to be produced more reliably and in scalable facilities.

Source: Scott Gottlieb testimony. See our previous posts here, here, here and here.

Dec 01, 2011 | 5 comments | by

How to Get Cheap Lipitor Tomorrow

Jason Shafrin says there are two easy ways:

  • Buy the generic form of Lipitor
  • Buy Lipitor

He adds:  “According to Marketplace, on Friday Lipitor will go off patent. On Thursday, the Indian drug company Ranbaxy will launch its generic at a low price. Pfizer will also lower the price of Lipitor to the generic levels.” He also takes a swipe at “pay-for-delay” and provides this link.

But why wait until tomorrow? I’ve been using generic Lipitor for several months. Can readers tell me how this is possible?

Nov 30, 2011 | 8 comments | by

A Label We Don’t Need

For almost two decades, the CCFL [WHO Committee on Food Labeling] has dealt with the (unnecessarily) contentious issue of whether foods derived from crops modified with recombinant DNA technology should have to be labeled as such. The obvious question is whether these products are sufficiently unique or pose dangers that should require such labeling. The scientific community has known the answer for a very long time. As Nature editorialized in 1992, “the same physical and biological laws govern the response of organisms modified by modern molecular and cellular methods and those produced by classical methods…. [Therefore] no conceptual distinction exists between genetic modification of plants and microorganisms by classical methods or by molecular techniques that modify DNA and transfer genes”. The US Food and Drug Administration (FDA) has explicitly rejected the labeling of food to indicate that it contains ingredients produced with recombinant DNA technology, as is the case for other genetic modification techniques.

Henry Miller, writing in Nature Biotechnology.

Nov 29, 2011 | 4 comments | by

Is The FDA Keeping Us Fat?

Two-thirds of Americans are overweight or obese. A Gallup poll found that 86% of full-time workers are overweight. A report in Health Affairs by Kenneth Thorpe, shows that 7% weight loss in just a small segment of the older adult population (60-64 year olds) could save Medicare as much as $15 billion. And the savings could be up to $35 billion if those individuals lost 10% of their body weight.

Despite this, last year the FDA rejected three new obesity therapies — Qnexa, Contrave, and Lorqess — the most promising of which, Qnexa, has been shown to bring about sustained weight loss greater than 10% of a person’s body weight. The FDA wanted additional evidence of the drugs were safe and effective in the short term; and evidence showing long-term weight loss. The rub is that the ingredients in two of the three therapies are known to be safe — they’re already FDA approved and widely available for treating migraines, depression, and other conditions. The first of the three drug makers is now going back to try again, having resubmitted its application for FDA approval.

Arguably, the main reason the FDA is hesitant to approve an obesity drug is because it considers nothing as safe for controlling weight as diet and exercise. However, diet and exercise generally fail. And there are few medications available — most of which are ineffective. That leaves surgery, a drastic step for many with a relatively high risk of death.

Without prescription weight-loss drugs, people turn to over-the-counter remedies, many of which are not very safe either. These include highly-caffeinated energy drinks that can raise blood pressure and herbal remedies bought on the Internet, many of which come from China and actually contain active ingredients that have been banned by the FDA.

Nov 10, 2011 | 14 comments | by

FDA: Hazardous to Your Health

When people age, the main valve carrying blood out of the heart becomes brittle. As this aortic valve narrows, it can cause debilitating heart failure, and even death. Fixing the problem in the United States requires open-heart surgery. In Europe, the problem can be repaired using a tiny catheter that introduces a replacement valve through an artery in the leg. In July, a Food and Drug Administration advisory panel said this device should also be approved for sale in the U.S. It is expected to reach patients by year end—more than four years after it first hit the market in Europe.

…more than 15,000 patients world-wide will receive the device by the time it’s slated for approval in the US. Some Americans healthy enough to fly have sought the procedure in Europe. Tens of thousands of Americans unable to travel, and too sick to undergo open-heart surgery; have died during the intervening four years.

See Scott Gottleib editorial in the Wall Street Journal

Oct 07, 2011 | 8 comments | by

E. Coli Outbreak. Did Environmentalists Cause It?

German Greens and their European Union acolytes have long fought scientific advances in food production and protection. After a spice manufacturer in Stuttgart employed the world’s first commercial food irradiation in 1957, West Germany banned the practice in 1959 and has since allowed few exceptions. So it’s no small scandal that the latest fatal E. coli outbreak has been linked to an organic German farm that shuns modern farming techniques.

Full article on the European food scare.

Jun 15, 2011 | 4 comments | by
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