Tag: FDA
The Decline in R&D Efficiency in the Drug Industry

Panel “a” in the graphic below shows that the number of new drugs approved by the U.S. Food and Drug Administration (FDA) per billion U.S. dollars spent on research and development (R&D) in the drug industry has halved about every nine years since 1950, in inflation-adjusted terms. This represents a decline in drug R&D…
Read More »

Game Developers Face Final Boss: The FDA

[This piece was later published by Newsweek and the Foundation for Economic Education.] “Absent the FDA, Americans would be healthier and happier.” —Robert Higgs As I drove to work the other day, I heard a very interesting segment on NPR that featured a startup designing video games to improve cognitive skills and relieve symptoms…
Read More »

Victory for Free Speech in Medicine

Judges are chipping away at government censorship of communications about prescription drugs. The Food and Drug Administration exerts great power over a medicine’s label, which describes the medicine’s therapeutic claims. Drug makers and the FDA sometimes spend years negotiating a label. The FDA regulates both safety and “efficacy.” So, a drug maker has to…
Read More »

Is FDA Reporting Drug Shortages Adequately?

For a number of years, there has been a problem of shortages of certain generic drugs for injection. These are often important cancer drugs. In 2012, I wrote a report that concluded over regulation by the Food and Drug Administration (FDA) was the primary cause of the shortages. The President and Congress acted, but…
Read More »

Breaking News: The FDA Will Not Regulate Your Kid’s Skateboard

The Food and Drug Administration has just issued draft guidance saying that it will not regulate products that help with “general wellness” and “promote a healthy lifestyle,” but pose low risk to peoples’ safety. The guidance specifies “exercise equipment, audio recordings, video games, software programs and other products” (although I suppose “other products” is…
Read More »

Using Marketable Vouchers to Speed Up Drug Approvals

The Food and Drug Administration recently approved a new drug for leishmaniasis, an extremely rare disease which is spread by sand flies in poor countries. Why would a for-profit company invest in inventing a drug for which there is no way to make a profit? The FDA offers a prize to any firm that…
Read More »

The FDA’s Productivity and Consistency Have Collapsed in a Decade

Joseph A. DiMasi, Christopher-Paul Milne, and Alex Tabarrok have written a devastating Report Card demonstrating how poorly the Food and Drug Administration (FDA) does its business. The FDA has a government-granted monopoly on deciding the safety and efficacy of new medicines. Nobody in America is allowed to choose to take a medicine not approved…
Read More »

FDA Continues to Impede Medical Device Innovation

In the Wall Street Journal this week, Dr. Scott Gottlieb discussed (gated, by subscription only) a worrying trend in the Food and Drug Administration’s regulation of medical devices. Increasingly, the FDA is demanding that device makers conduct trials of new devices by randomly assigning patients to the new device . . . or to…
Read More »

FDA Regulations Kill

Paul Howard and Yevgeniy Feyman in Health Affairs: Meningitis is a terrible disease that can kill its victims in a single day. About 4,100 new cases are diagnosed annually in the U.S., with a mortality rate of more than 10 percent. Even with treatment, survivors are often left with serious side effects that can…
Read More »

Federal Government Gives Patients a New “Right”: Access to Lab Results

Many patients groups and their allies understandably cheered a new regulation that just came about as a result of many years of advocacy: Nationwide, patients now have a “right” to access their lab results directly. The “right” to receive test results directly from labs now ranks equally with the “right” to get our medical…
Read More »

  • Catalyst
  • MyGovCost.org
  • FDAReview.org
  • OnPower.org
  • elindependent.org