Executive Summary 

Adverse event reporting data will also be more readily available, Commissioner Scott Gottlieb says.

The US FDA is looking to routinely publish clinical data used in regulatory decision making along with adverse event reporting data, in what appears to be just the latest effort of Commissioner Scott Gottlieb’s high profile effort to enhance transparency at the agency.

Speaking at the POLITICO Pro Summit Sept. 14, Gottlieb explained that sometimes FDA develops its own datasets based on submitted datasets from sponsors to help the agency make its own decisions. The agency is looking to make such clinical information available if it has “public health relevance,” Gottlieb says.

“My view is that if we are developing a novel dataset that we are using for regulatory decision making, we ought to think about how we provide public access to that, because it is becoming a regulatory tool we are using, people should be able to query it and assess our work,” Gottlieb said.

The commissioner admitted there will be some difficulties publishing certain data, such as issues with informed consent, which the agency will need to be mindful of as it pursues the initiative.

What’s more, Gottlieb said FDA is also looking to allow for “more wholesale access” to adverse event reporting data that is submitted to the agency. Gottlieb noted that clinicians sometimes have difficulties searching for such data.

The FDA Adverse Event Reporting System (FAERS) is a database that contains information on adverse event and medication error reports submitted to the agency. Users can search FDA’s website for statistics on the numbers of reports submitted to the agency for drugs over the past 10 years. Currently, however, one must be familiar with creation of relational databases to search the raw data consisting of individual case safety reports.

REMS Letters To Come As Well

Gottlieb also confirmed that FDA will “very soon” be publishing letters sent to brand drugmakers that inform them it is permissible to sell products with a risk evaluation and mitigation strategy (REMS) to generic sponsors for bioequivalence testing.

REMS abuse has been an issue Gottlieb has spoken on several times since his confirmation as commissioner in May. He first floated the idea of the public shaming tactic at a July meeting on the Hatch-Waxman Act. (Also see “FDA Exploring Whether Public Shaming Can Stop REMS Abuses” – Pink Sheet, 18 Jul, 2017.)

“Right now, those letters are sent directly to the branded companies and the generic sponsors,” Gottlieb said. “That is another place we are going to provide more transparency. We think that’s important in this case for promoting competition in the market. And we think competition is a matter of public health.”

Gottlieb has also discussed how the agency is looking at its own internal options to address the issue of REMS abuse. (Also see “Gottlieb Talks Activist Role For FDA In Curbing REMS Abuse” – Pink Sheet, 20 Jun, 2017.)

A New Level Of Transparency?

Since taking the reins of FDA in May, Gottlieb appears to be promoting a level of transparency at the agency beyond that of his predecessors, with his remarks at the POLITICO Pro Summit just being the latest example.

In addition to efforts in making data more publicly available, Gottlieb has been very active over the past few weeks alone personally making public appearances to discuss the future of the agency.

At the Regulatory Affairs Professionals Society Regulatory Convergence Conference on Sept. 11, Gottlieb announced that the agency will begin working on 10 new disease-specific development guidance documents over the next year as part of FDA’s steps on the clinical front to help make drug development more efficient. (Also see “FDA’s Gottlieb Pushing ‘Seamless’ Clinical Trials For Faster Development” – Pink Sheet, 11 Sep, 2017.) He also noted that he would like the agency to conduct more systemic reviews of its regulations. (Also see “Gottlieb Wants More Systematic Updates Of Regulations” – Pink Sheet, 12 Sep, 2017.)

The next day at a Friends of Cancer Research meeting the following day, Gottlieb announced that one of the disease-specific guidances will include Alzheimer’s. (Also see “Alzheimer’s Guidance Coming From US FDA, Part Of Broader OND Reform” – Pink Sheet, 14 Sep, 2017.)

Speaking at Research America’s National Health Research Forum Sept. 7, Gottlieb explained that the agency may require less pre-clinical data for certain second entry therapies that involve new technology platforms. (Also see “Gene Therapy Platforms May Require Less Preclinical Data, Gottlieb Says” – Pink Sheet, 7 Sep, 2017.)

Gottlieb is also scheduled to speak Sept. 29 at the National Press Club about modernizing the role of FDA’s medical staff.

Additionally, Gottlieb has also outpaced his most recent successors in appearing in FDA press statements. Since taking over the commissioner role, there have been 24 total statements that are either entirely attributable to Gottlieb or contain a quote from him. That number tops Robert Califf’s total of seven over his first four months, and Margaret Hamburg’s total of 20 during the same timeframe.

Gottlieb has already topped Califf’s total number of FDA media release appearances, as the Barack Obama appointee appeared in 13 total statements during his roughly 11 months as the head of the agency.

The large number of press release appearances from Gottlieb may be due in part to 2017 being a year of user fee renewals, warranting comments from the new commissioner.

https://pink.pharmamedtechbi.com/PS121575/US-FDA-To-Publish-Own-Dataset…