Proposed FDA Generic Drug Regulation: Higher Prices, No Public Health Benefit

March 12, 2014

Proposed FDA Generic Drug Regulation: Higher Prices, No Public Health Benefit. By Scott Gottlieb, MD; Alex Brill; and Robert W. Pollock

Key points in this Outlook:

• A new regulation proposed by the Food and Drug Administration will compel generic drug makers to update their drug labels to reflect purported “new” safety issues.

• The regulation will result in increased drug prices and leave generic drug firms vulnerable to “failure to warn” tort suits, but produce no public health benefit.

• It would be far more efficient and effective for the FDA to review generic drug labels itself. Alternatively, generic drug makers could undertake additional responsibilities without additional liability.

Full report.


Scott Gottlieb: The FDA Wants You for Sham Surgery – WSJ.com

February 19, 2014

Yet research that introduces harm or risk with no opportunity for benefit would seem to conflict with the principles governing research on humans. Some of these are reflected in the Declaration of Helsinki, an international treaty concerning the conduct of medical research. Other experiments using sham surgeries are obligating patients to undergo unnecessary anesthetics, radiation, abdominal incisions, endoscopy and injections into the rectum, to mention a few examples. The needless cutting means pain as well as the risk of anesthesia and infection.

The FDA tries to address ethics issues by letting patients who get sham treatments eventually join the real treatment group. But this often requires a second surgery. The sham trials can also be costly because they involve unnecessary operations. They are hard to recruit for when patients know they may get a fake surgery and are reluctant to consent to being cut unnecessarily.

All of this raises development costs—and it encourages firms to skip the U.S. market and commercialize new products overseas. This can suppress innovation.

via Scott Gottlieb: The FDA Wants You for Sham Surgery – WSJ.com.


Drug Companies Join NIH Against Alzheimer’s, Diabetes, Rheumatoid Arthritis, Lupus – WSJ.com

February 4, 2014

Ten big drug companies that have spent billions racing one another to find breakthroughs on diseases like Alzheimer\’s have formed an unusual pact to cooperate on a government-backed effort to accelerate the discovery of new medicines.

Under a five-year collaboration to be announced on Tuesday, the companies and the National Institutes of Health have agreed to share scientists, tissue and blood samples, and data. They aim to decipher the biology behind Alzheimer\’s, Type 2 diabetes, rheumatoid arthritis and lupus, and to thereby identify targets for new drugs.

The price tag, roughly $230 million, is relatively small: The global drug industry spends about $135 billion a year on research and development. But the collaborators seek something money can\’t buy.

By pooling their brightest minds and best lab discoveries they hope to put together a research system that can decipher the diseases in ways each hasn\’t been able to on its own.

via Drug Companies Join NIH Against Alzheimer’s, Diabetes, Rheumatoid Arthritis, Lupus – WSJ.com.


Beyond Economics: How Price Controls Are Killing Millions Of Patients – Forbes

January 3, 2014

Due to maximum-wage policies, it currently takes about a decade for working medical therapies to reach patients. Stronger incentives in the clinical trial process responsible for the delays would leave product safety unaltered, but would save millions of lives.

via Beyond Economics: How Price Controls Are Killing Millions Of Patients – Forbes.


Henry I. Miller: Critics of ‘Me-Too Drugs’ Need to Take a Chill Pill – WSJ.com

January 2, 2014

in a study in the journal Nature Reviews Drug Discovery in 2011, Joseph DiMasi and Laura Faden of the Tufts Center for the Study of Drug Development persuasively debunked the myth that drug companies purposely produce duplicative me-too drugs. They closely examined drug-development patterns and timing and found that the process is best viewed as \”a race in which several firms pursue investigational drugs with similar chemical structures or with the same mechanism of action before any drug in the class obtains regulatory marketing approval.\” In other words, companies are not starting out to develop a me-too product any more than a marathon runner starts a race intending to be an also-ran.

via Henry I. Miller: Critics of ‘Me-Too Drugs’ Need to Take a Chill Pill – WSJ.com.


Obama White House Sides With Trial Bar At Costly Expense of Generic Drug Makers – Forbes

December 19, 2013

The FDA has issued a new regulation that could open generic drug makers to the same sort of product liability suits that plague branded pharmaceutical companies.

It’s part of a political effort by the Obama Administration to find a regulatory end run around its failed bids to attain the same result in the courts and on Capitol Hill.

But the new rule will jeopardize the business model that has given the U.S. the world’s most vibrant, and low cost market for generic medicines.

via Obama White House Sides With Trial Bar At Costly Expense of Generic Drug Makers – Forbes.


Review: The Cure in the Code – WSJ.com

December 4, 2013

We are at a turning point in medicine. Knowledge of the individual\’s genetic makeup will soon allow molecular medicine to reach deep inside each of us to cure most of the maladies that afflict us—and perhaps even slow the rate at which we age. First we will learn to understand each person\’s genome; then we will learn to craft treatments tailored to his or her genetic constitution.

But it may not be so easy—and not for purely scientific reasons. Consider 23andMe, a commercial enterprise launched in 2006 that was merely looking to inform Americans about their potential genetic vulnerability to certain diseases. Regulators from the Food and Drug Administration have dropped the hammer on the company, citing baseless fears that its customers will do something dangerously stupid in reaction to the information that the tests provide. The FDA\’s regulatory labyrinth is not only slow to digest the science behind the genetic testing involved in 23andMe. It also can\’t quite figure out what to do with the proliferation of molecular biomarkers that can predict treatment efficacy more quickly than the conventional clinical trials the agency relies upon.

All this is just the tip of the iceberg, Peter Huber argues in \”The Cure in the Code,\” his urgent, compelling account of how 21st-century medicine is being hampered by a regulatory regime built for the science of the 20th century.

via Review: The Cure in the Code – WSJ.com.


Building a 21st Century FDA: Advancing Science, Saving Lives – YouTube

December 2, 2013

Through one man\’s story, Project FDA\’s new video shows how new technology can enable us to triumph over once-intractable diseases –if the FDA can adapt outdated regulations to fit a new medical reality. The video features interviews with Manhattan Institute senior fellow Peter Huber, author of CURE IN THE CODE: HOW 20TH CENTURY LAW IS UNDERMINING 21ST CENTURY MEDICINE, 23andMe co- founder Linda Avey, and others.

via Building a 21st Century FDA: Advancing Science, Saving Lives – YouTube.


23andMe Is Terrifying, But Not for the Reasons the FDA Thinks: Scientific American

November 28, 2013

But as the FDA frets about the accuracy of 23andMe’s tests, it is missing their true function, and consequently the agency has no clue about the real dangers they pose. The Personal Genome Service isn’t primarily intended to be a medical device. It is a mechanism meant to be a front end for a massive information-gathering operation against an unwitting public.

Sound paranoid? Consider the case of Google. (One of the founders of 23andMe, Anne Wojcicki, is presently married to Sergei Brin, the founder of Google.) When it first launched, Google billed itself as a faithful servant of the consumer, a company devoted only to building the best tool to help us satisfy our cravings for information on the web. And Google’s search engine did just that. But as we now know, the fundamental purpose of the company wasn’t to help us search, but to hoard information. Every search query entered into its computers is stored indefinitely. Joined with information gleaned from cookies that Google plants in our browsers, along with personally identifiable data that dribbles from our computer hardware and from our networks, and with the amazing volumes of information that we always seem willing to share with perfect strangers—even corporate ones—that data store has become Google’s real asset. By parceling out that information to help advertisers target you, with or without your consent, Google makes more than $10 billion every quarter.

via 23andMe Is Terrifying, But Not for the Reasons the FDA Thinks: Scientific American.


How 23andMe Broke the Rules: The F.D.A. Versus Personal Genetic Testing : The New Yorker

November 28, 2013

Aggravating the conflict is a cultural clash between Silicon Valley, with its devotion to libertarianism and self-knowledge, and a ponderous old-school bureaucracy. But as the veteran journalist and F.D.A. watchdog Matthew Herper notes in one of the sharpest pieces written on this debacle, the agency’s investment into at least four years of negotiations suggests that it was trying to be accommodating. Herper reluctantly concluded that 23andMe is “either … deliberately trying to force a battle with the F.D.A., which I think would potentially win points for the movement the company represents but kill the company itself, or it is simply guilty of the single dumbest regulatory strategy I have seen in 13 years” of covering the F.D.A.

via How 23andMe Broke the Rules: The F.D.A. Versus Personal Genetic Testing : The New Yorker.


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