Spring Regulatory Agenda for FDA: What New Rulemakings are Coming

Regulatory NewsRegulatory News
| 22 May 2019 | By Zachary Brennan 

The US Food and Drug Administration (FDA) on Wednesday published its plans for the latest proposed and final rulemakings for drug and medical device companies, with new proposals related to the Right to Try law, investigational new drug (IND) application reporting requirements and amendments to patent term restoration.

First Time Published in Unified Agenda

The proposed rulemaking related to the Right to Try Act of 2017, which cut FDA out of the process of granting certain compassionate use requests to investigational medicines, would require an annual summary from sponsors and manufacturers who provide an eligible investigational drug for use by an eligible patient.

“The Act requires FDA to specify by regulation the due date for the annual summary. This regulation will fulfill that requirement. Because the Act states regulation is required, FDA is not considering any alternatives to address the problem,” the plan for the rulemaking says, noting that it’s expected to be proposed in September.

FDA’s proposal is controversial because Sen. Ron Johnson (R-WI) said last May that the Right to Try Act is meant to “diminish the FDA’s power… It is not meant to grant the FDA more power or enable the FDA to write new guidance, rules, or regulations that would limit the ability of an individual facing a life-threatening disease from accessing treatments.”

Just two patients have accessed an investigational drug under the one-year-old law.

In addition to the Right to Try proposal, FDA is also seeking to release a proposed rule next March that would ease the burden of FDA’s requirements related to IND annual reports. The proposal would replace the current annual reporting requirement with a new requirement for a “development safety update report.” The plan is intended to better align with the International Council for Harmonisation and the report will be “more comprehensive, informative, and less burdensome than the IND annual report currently required by FDA.”

Meanwhile, next February, FDA is also proposing to amend its Patent Term Restoration regulations to “identify the effective date of approval for scheduled drugs, to define when the beginning of the 60-day review period occurs, including the term business day and to explain how approvals after 4:30 p.m. fit in this definition. The proposed amendments will make existing FDA regulations consistent with the statutory amendments.”

Previously Published in Unified Agenda

Drug and medical device companies can also expect to see more than a dozen proposed and final rulemakings on everything from post-approval changes to FDA imposing clinical holds for certain medical device trials.

That proposed rule on clinical holds, expected in February 2020, would create a regulatory framework and procedures for suspending any medical device clinical investigation. The proposed rule would implement section 606 of the Food and Drug Administration Safety and Innovation Act from 2012.

In September, FDA also plans, as previously announced, to release a proposed rulemaking on harmonizing and modernizing the quality system regulations for devices. “The revisions will supplant the existing requirements with the specifications of an international consensus standard for medical device manufacture, ISO 13485:2016. The revisions are intended to reduce compliance and recordkeeping burdens on device manufacturers by harmonizing domestic and international requirements,” FDA said.

In December, in line with the 21st Century Cures Act, FDA will propose to exclude certain medical software functions from the agency’s jurisdiction.

And next month, FDA plans to release a proposed rule to amend its device regulations to discontinue publishing in the Federal Register after each quarter a list of premarket approval applications (PMAs) and humanitarian device exemption applications (HDEs). But FDA still plans to continue to post such information online and to make copies of the current PMA and HDE approval and denial documents, as well as other documents available through the Division of Dockets Management.

On the pharmaceutical side, FDA is planning a proposed rule for next March to update the existing regulations governing supplements and other changes to approved new drug applications (NDAs), abbreviated new drug applications (ANDAs) and biologics license applications (BLAs), as well as regulations regarding certain post-approval reports.

Also next March, FDA will look to update existing regulations governing supplements and other changes to approved NDAs, ANDAs and BLAs, as well as regulations regarding certain post-approval reports.

Next December, FDA’s biologics regulations will be updated to clarify existing requirements and procedures related to BLAs and to promote the goals associated with FDA’s implementation of the abbreviated licensure pathway created by the Biologics Price Competition and Innovation Act of 2009.

Another IND proposed rulemaking is also planned for April 2020 and would update FDA’s regulations to define and clarify the roles and responsibilities of the various persons engaged in the initiation, conduct and oversight of clinical investigations subject to IND requirements.

“The proposed changes should better protect the rights, safety, and welfare of subjects participating in clinical investigations and help ensure the integrity of clinical trial data,” FDA said. 

Another research-related proposed rulemaking planned for August would replace current FDA requirements for cooperative research so that any institution located in US and participating in multi-site cooperative research would need to rely on approval by a single Institutional Review Board, with some exceptions.

The Trump Administration also pushed back two other drug pricing proposals related to their proposed use of an International Pricing Index and point-of-sale rebates.

Editor's note: Article updated to note that two patients have accessed investigational drugs under the Right to Try law, not one. The second one was Matt Belina. The first was an unidentified brain cancer patient in California.


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