FDA Watch

 

Congress Protects Healthcare — For Now

May 3, 2017
Congress Protects Healthcare -- For Now

Congress’ fiscal 2017 spending bill boosts funding for critical medical research and health programs. But will they do the same for fiscal 2018?

Are There Side Effects Associated with At-Home Genetic Health Risk Tests?

April 19, 2017
Are There Side Effects Associated with At-Home Genetic Health Risk Tests?

An at-home test that analyzes the DNA in saliva to determine a person’s risk for certain diseases sounds like a good idea. But there are some not so obvious side effects associated with it.

How Abuse of the Orphan Drug Program Hurts Patients

April 5, 2017
How Abuse of the Orphan Drug Program Hurts Patients

The Orphan Drug Act was created to encourage drugmakers to develop medicines for rare diseases. So why is it many drugs win approval as orphan drugs even though they are also used for “mass market” diseases?

What Happens When an Approved Drug Isn’t That Effective?

March 22, 2017
Many drugs are approved that aren't all that effective in the "real world." Why is the FDA approving drugs that don't really work?

Many drugs are approved that aren’t all that effective in the “real world.” Why is the FDA approving drugs that don’t really work?

FDA Needs to Stand Up to Off-Label Marketing Efforts

March 8, 2017
FDA Needs to Stand Up to Off-Label Marketing Efforts

The pharma industry is pushing back on efforts by the FDA to restrain off-label promotion of drugs. Public health would be harmed if a new rule is changed.

Are Clinical Trial Participants Really That Diverse?

February 15, 2017
Are Clinical Trial Participants Really That Diverse?

The FDA this week released its Drug Trials Snapshots Summary Report, a document that looks at the diversity of the participants in trials for new drugs that were approved last year and in 2015. There’s a lot to be excited about. For example, women accounted for 48% of Continue Reading →

Trump and the Undermining of the FDA

February 1, 2017
Trump and the Undermining of the FDA

President Trump has been making policy decisions that directly impact health care. Most of them are not good for patients.