The majority of moderate- to high-risk medical devices approved by the U.S. Food and Drug Administration lack publicly available scientific evidence to verify their safety and effectiveness despite requirements in the law, according to a study released Monday.Researchers reported in JAMA Internal Medicine that 42 of 50 selected medical devices cleared by the FDA over five years lacked such data, despite a 1990 law calling for sufficient detail to justify their FDA clearance. The law calls for public data about studies, which may include clinical studies, involving human patients.
There’s growing frustration among entrepreneurs in Silicon Valley who are finding that the road to improving medical technology ends not in Palo Alto but in White Oak, Md.—at the headquarters of the Food and Drug Administration. “Health is just so heavily regulated,” Google co-founder Sergey Brin complained last month to a group of high-tech CEOs, “it’s just a painful business to be in.”The pain has become especially acute in the burgeoning field of mobile medical apps and health-care…
For decades, the FDA had chosen not to actively regulate laboratory-developed tests, or LDTs, because they tended to be simple devices used to diagnose rare or “low-risk” diseases. In recent years, however, the tests have become more widely used and more specialized, able to diagnose specific forms of cancer and other diseases with complex genetic data.Government regulators say the evolution makes it more critical than ever to ensure that the tests are safe and trustworthy and that patients who rely on them aren’t misdiagnosed. Several incidents in recent years have underscored those concerns, including instances in which the reliability of LDTs for cervical cancer, Lyme disease and whooping cough have been questioned.
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.