there would be a great benefit to a system like that promoted by Kling, which Kling himself does not describe. Pharmaceutical enterprises are corporate bureaucracies that blend R&D functions with sales and marketing, regulatory affairs, government relations, and other non-research functions. Licensing can overcome some of the managerial diseconomies of scope in such an organization. However, if there were a new system of pharmaceutical innovation that would allow more specialization in R&D versus other functions, that would be an exceedingly beneficial public-policy achievement.
The US Food and Drug Administration (FDA) uses rulemaking as one of its primary tools to protect the public health and implement laws enacted by Congress and the president. Due to the many effects that these rules have on social welfare and the economy, the FDA and other executive agencies receive input from the executive branch, the public, and in some cases, the courts, during the process of rulemaking. In this article, we examine the life cycle of FDA regulations concerning medical products and review notable features of the rulemaking process. The current system grants substantial opportunities for diverse stakeholders to participate in and influence how rules are written and implemented. However, the duration, complexity, and adversarial qualities of the rulemaking process can hinder the FDA’s ability to achieve its policy and public health goals. There is considerable variation in the level of transparency at different stages in the process, ranging from freely accessible public comments to undisclosed internal agency deliberations. In addition, significant medical product rules are associated with lengthy times to finalization, in some cases for unclear reasons. We conclude by identifying potential areas for reform on the basis of transparency and efficiency.
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.
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.
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.
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.
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.
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.
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.
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.