FDA Aims To Study How Rx Drug Promo Affects Patient, Physician Choices

FDA hopes to conduct a study assessing how prescription drug promotion, and in particular information about a drug’s efficacy, risks and adherence, affects medication decisions by consumers and providers, the agency announced Friday (April 22). The proposed study will focus on medications for type 2 diabetes and psoriasis. There is currently little information on the tradeoffs patients make when considering drug product characteristics and how the tradeoffs could potentially differ from the tradeoffs made by physicians, FDA says in its...
Article Type: 
Tags: 
Site Name: 
InsideHealthPolicy.com
FDA Issue: 
FDA Week - 04/29/2022
FDA Volume: 
Vol. 28, No. 17
Author: 

FDA Unveils Draft NAC Policy, Supplement Orgs Urge Permanent Solution

FDA unveiled a proposed enforcement discretion policy saying it won’t take action against dietary supplements containing N-acetyl-L-cysteine (NAC), as long as they’re not adulterated or misbranded. Dietary supplement groups say FDA’s proposal offers a short-term compromise, but they add there still needs to be a long-term solution to prevent agency overreach and ensure consumers have access to NAC-containing supplements in the future. The agency is reviewing data on NAC, which is approved as a drug ingredient and under law is...
Article Type: 
Site Name: 
InsideHealthPolicy.com
FDA Issue: 
FDA Week - 04/29/2022
FDA Volume: 
Vol. 28, No. 17
Author: 


ICER Proposes Creating Ultra-Rare Orphan Drug Class

Congress should consider creating a new category of “ultra-rare” drugs, boost incentives for those drugs, and take away some of the incentives for so-called partial orphan drugs, according to policy reforms explored by the Institute for Clinical and Economic Review in an April 7 white paper . ICER President Stephen Pearson said he worries that evidence requirements for orphan drugs are weakening, and it’s not clear that the health care system can afford orphan drugs as they become more common...
Article Type: 
Site Name: 
InsideHealthPolicy.com
IDP Issue: 
Inside Drug Pricing - 04/25/2022
IDP Volume: 
Vol. 5, No. 17
Author: 












Pages

Log in to access this content.

Not a subscriber? Sign up for 30 days free access to exclusive, detailed reporting on drug pricing reforms, Medicaid policy, FDA news and much more.