FDA Watch

 

Is the FDA Really That Slow at Approving Drugs?

July 19, 2017
Is the FDA Really That Slow at Approving Drugs?

One of the most often heard complaints about the FDA is that it is too slow to approve drugs.

During his first address to Congress in February, President Trump said that the agency is saddled with a “slow and burdensome approval process” that is keeping many drugs from getting to Continue Reading →

Are Direct-to-Consumer Ads Portraying Drug Risks Effectively?

June 28, 2017
Are Direct-to-Consumer Ads Portraying Drug Risks Effectively?

Do consumers pay attention to the risks and side effects listed in drug ads? The FDA wants to find out since there is concern consumers are bombarded with risk information, making them less likely to pay attention to them.

The Fallacy of Abuse-Deterrent Opioids

June 14, 2017
The Fallacy of Abuse-Deterrent Opioids

Many Rx opioids claim to be abuse deterrent, but the reality is they do little to curb this. A better approach is to curb prescribing of the painkillers.

Safe Only When Taken as Directed

May 31, 2017
Safe Only When Taken as Directed

Taking a drug incorrectly can lead to preventable harm. But the FDA and other stakeholders aim to minimize that through the Safe Use Initiative.

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?