During his first appearance before Congress as FDA Commissioner on May 25, 2017, Scott Gottlieb reported that the Agency is preparing a \u201cDrug Competition Action Plan\u201d that it will unveil in upcoming weeks and months. This was likely welcome news to many politicians from both parties, as well as to President Trump, who has publicly shamed pharmaceutical companies for the high prices of their products but has done little to advance concrete policies in this area.<\/p>\n\n\n\n
Dr. Gottlieb has been consistent over the years, including during his recent confirmation process, in his view that FDA should take a more active role in fostering competition and reducing unnecessary regulatory barriers. So it was not surprising when he was selected by Trump to lead the Agency, nor when he received a relatively warm welcome from Senators concerned about the direction prices have been going in recent years. Although it\u2019s not expected to be a magic bullet that will automatically result in price reductions or cost savings for insurers and patients, a more competitive marketplace for drugs and biologics may have an impact on some of the factors that contribute to what many stakeholders feel are unreasonably high drug prices.<\/p>\n\n\n\n
Some of the elements Dr. Gottlieb suggested may be included in the upcoming FDA Drug Competition Action Plan include:<\/p>\n\n\n\n
Dr. Gottlieb also noted that one of the goals of this broader initiative is to \u201ccurtail gaming by industry of our regulations which can extend monopolies beyond the timeframe that Congress intended, hindering competition.\u201d<\/p>\n\n\n\n
On that point, REMS that incorporate restricted-distribution programs for the products they cover have been cited for years as impeding the rapid development of generic and biosimilar versions of those products. Dr. Gottlieb indicated that he and his staff would also be convening a Part 15 public hearing to gather input from stakeholders about how and when alleged manipulation of the REMS system occurs, and the best ways for FDA to address such issues. At least two bills have been introduced in the current Congress to make changes to the legal provisions that created the Agency\u2019s REMS authorities in 2007, and many others have failed in prior years. We will be watching how FDA tackles this and other controversial policy changes. Stay tuned!<\/p>\n","protected":false},"excerpt":{"rendered":"
During his first appearance before Congress as FDA Commissioner on May 25, 2017, Scott Gottlieb reported that the Agency is preparing a \u201cDrug Competition Action Plan\u201d that it will unveil in upcoming weeks and months. This was likely welcome news to many politicians from both parties, as well as to President Trump, who has publicly shamed pharmaceutical … Read more<\/a><\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_generate-full-width-content":""},"categories":[1],"tags":[],"_links":{"self":[{"href":"https:\/\/www.healthlawpolicymatters.com\/wp-json\/wp\/v2\/posts\/4471"}],"collection":[{"href":"https:\/\/www.healthlawpolicymatters.com\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.healthlawpolicymatters.com\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.healthlawpolicymatters.com\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.healthlawpolicymatters.com\/wp-json\/wp\/v2\/comments?post=4471"}],"version-history":[{"count":1,"href":"https:\/\/www.healthlawpolicymatters.com\/wp-json\/wp\/v2\/posts\/4471\/revisions"}],"predecessor-version":[{"id":4472,"href":"https:\/\/www.healthlawpolicymatters.com\/wp-json\/wp\/v2\/posts\/4471\/revisions\/4472"}],"wp:attachment":[{"href":"https:\/\/www.healthlawpolicymatters.com\/wp-json\/wp\/v2\/media?parent=4471"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.healthlawpolicymatters.com\/wp-json\/wp\/v2\/categories?post=4471"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.healthlawpolicymatters.com\/wp-json\/wp\/v2\/tags?post=4471"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}