Bills
| 3.23.22

Should New Drugs Be Approved (Or Denied) Faster? (H.R. 639)

Do you support or oppose this bill?

What is H.R. 639?

(Updated July 18, 2017)

This bill was enacted on November 25, 2015

When pharmaceutical companies want to introduce a new medicine to U.S. patients, it must first go to the Food & Drug Administration (FDA) for approval. After this, these medicines go to the Drug Enforcement Agency (DEA), where that agency must approve them, too. 

This bill aims to accelerate the approval process by requiring the DEA to come to a scheduling decision within 60 days of a drug product passing FDA approval. 

This legislation would also speed up the process to bring new drugs under a clinical trial. The DEA would be given a 180 day window to approve or deny an application to manufacture a controlled substance (Schedule III, IV or V) for clinical trial. 

Argument in favor

Would help ensure that new treatment options reach patients in a timely manner.

Argument opposed

Rushing approval of experimental medicines has the potential to backfire widely and lethally.

Impact

Sick patients, new pharmaceuticals and other medicines awaiting DEA approval, healthcare providers, researchers in clinical trials, the FDA, and the DEA.

Cost of H.R. 639

A CBO cost is currently unavailable, though if enacted, an increase in labor hours at the DEA would seem likely, and this might in turn raise the DEA's budget.

Additional Info

Of Note:

According to an Op-Ed in The Hill in support of a previous version of this bill from the 113th Congress:

"Between 1997-1999 and 2009-2013, the time between FDA approval of a medicine and DEA’s final scheduling increased from an average of 49 days to an average of 238 days, an almost five-fold increase."

Media:




(Photo Credit:  Flickr user kaibara87)