Gottlieb An Anchor For OTC Drug Industry On Stormy Congressional Seas
This article was originally published in The Pink Sheet & The Rose Sheet
Commissioner Gottlieb has been a “very strong champion” of FDA and his interest in improving the OTC monograph and switch processes provides hope to the industry during a tumultuous legislative era, say CHPA executives at their annual meeting in Florida. They expect monograph reform will happen this year but doubt much else will happen before mid-term elections in November.
You may also be interested in...
While Rx drug pricing is under attack by Congress, White House and consumer and public health advocacy groups, OTC drugs' value isn't gaining a higher profile. "Our health care system undervalues the contribution of our industry's products," says CHPA chief Scott Melville. Trade group conducts “Value of OTC Medicines" study for reasons including raising the profile of consumer health products in the US health care system.
FDA seeks broader guidance than comments and information submitted at a January public hearing on standards testing and evaluations that could expand the variety of products approved as NRTs The docket is open to "recommend specific topics for direct, collective engagement and consideration by the" steering committee.
President Trump's FY 2019 budget request includes $473m in new non-user fee revenue for the US agency, a reversal of the previous year's request.