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# New Opioid Approval Standard Needed: Gottlieb
- URL: https://www.fdaweb.com/new-opioid-approval-standard-needed-gottlieb/
- Published: 2019-03-28T12:00:00.000Z
- Updated: 2026-09-15T01:16:24.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143728

FDA commissioner **Scott Gottlieb** told a Senate Appropriations Committee subcommittee 3/28 that a new comparative standard is needed for approving new opioid drugs. Gottlieb made the comment during a [hearing](https://www.appropriations.senate.gov/hearings/review-of-the-fy2020-budget-requests-for-the-fda?ref=fdaweb.com) into the FDA FY 20 budget request that includes a 5.5% increase over FY 19, one of the largest increases of any HHS agency. He said he believes FDA should be treating opioids as a class different from other drugs and should require sponsors to demonstrate that any new opioid provides a significant advantage in terms of efficacy and safety over existing products. He said he hoped such an approach could incentivize development of non-opioid alternatives and called on Congress to consider other incentives such as exclusivity.

In response to questions, Gottlieb said: 

- FDA has issued guidance on a new pathway for drugs that are used to wean people from opioids;
- the nature of the nation’s opioid crisis is changing from being based on prescribed drugs to stemming from illicit drugs;
- rather than considering the volume of illicit drugs flooding the country, regulators need to be looking at the potency of the drugs;
- people are becoming adept at disguising illicit opioids, such as sending them in smaller packages or making them look like OTC products;
- FDA will take enforcement against CBD (cannabidiol) products if the companies make claims the agency believes are “over the line”;
- FDA is expecting that there will be considerable activity for a generic insulin under the biosimilar pathway;
- some non-opioid painkillers that are in development look promising and some could be eligible for a breakthrough designation to speed their approval;
- FDA is trying to increase drug competition through approval of generic drugs and second-generation branded products but has no way to promote price competition.

 Gottlieb’s prepared opening statement is [here](https://www.fda.gov/NewsEvents/Testimony/ucm634647.htm?ref=fdaweb.com).