FDA Commissioner Scott Gottlieb, MD, said that the agency plans to require opioid manufacturers to fund studies examining their products’ efficacy for chronic pain, The Washington Post reported. According to the article, Dr Gottlieb announced that the FDA will make labeling changes, implement special prescribing and dispensing rules, and even prohibit opioid use if the products are found ineffective. The FDA-mandated research will focus on all immediate, long-acting, and extended-release opioids prescribed to patients for use outside of health care settings, the article reported.
Sen. John Cornyn (R-Texas) said that the Senate Judiciary Committee will investigate whether drug companies game the patent system to delay generic competition, The Hill reported. According to the article, this follows a Senate Finance Committee hearing held on Tuesday in which AbbVie CEO Richard Gonzalez was questioned regarding the company’s practices in delaying competition for its drug adalimumab (Humira). Sen. Chuck Grassley (R-Iowa) said he supports having the Judiciary Committee look into the issue further, the article reported.
