PR Tufts CSDD 2014 Cost Study | Tufts Center for the Study of Drug Development

November 18, 2014

Developing a new prescription medicine that gains marketing approval, a process often lasting longer than a decade, is estimated to cost $2,558 million, according to a new study by the Tufts Center for the Study of Drug Development.

The $2,558 million figure per approved compound is based on estimated:

  • Average out-of-pocket cost of $1,395 million
  • Time costs expected returns that investors forego while a drug is in development of $1,163 million

Estimated average cost of post-approval R&D—studies to test new indications, new formulations, new dosage strengths and regimens, and to monitor safety and long-term side effects in patients required by the U.S. Food and Drug Administration as a condition of approval—of $312 million boosts the full product lifecycle cost per approved drug to $2,870 million. All figures are expressed in 2013 dollars.

via PR Tufts CSDD 2014 Cost Study | Tufts Center for the Study of Drug Development.

Medical Devices Lack Safety Evidence, Study Finds | National Center For Health Research

September 30, 2014

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.

via Medical Devices Lack Safety Evidence, Study Finds | National Center For Health Research.

Scott Gottlieb and Coleen Klasmeier: Why Your Phone Isn’t as Smart as It Could Be – WSJ

August 7, 2014

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…

via Scott Gottlieb and Coleen Klasmeier: Why Your Phone Isn’t as Smart as It Could Be – WSJ.

FDA to begin regulating laboratory test devices – The Washington Post

August 2, 2014

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.

via FDA to begin regulating laboratory test devices – The Washington Post.

“Prize-Grants” or Patents for Pharmaceutical Innovation? | The Beacon

July 21, 2014

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.

via “Prize-Grants” or Patents for Pharmaceutical Innovation? | The Beacon.

Life Cycle of Medical Product Rules Issued by the US Food and Drug Administration

May 19, 2014

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.

via Life Cycle of Medical Product Rules Issued by the US Food and Drug Administration.

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.


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