Tag: FDA

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The Food and Drug Administration has just issued draft guidance saying that it will not regulate products that help with “general wellness” and “promote a healthy lifestyle,” but pose low risk to peoples’ safety.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 »

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