FDA News

FDA issues draft guidance to promote competition, access to drugs

Scott Gottlieb
Scott Gottlieb

The FDA released several draft guidances today that it said it hopes will assist generic drug makers get their products through the development and approval process while keeping the agency’s Risk Evaluation and Mitigation Strategy, or REMS, safety controls in place.

“Bringing together multiple products under one REMS program can have real benefits for the health care system, including for providers. But, the generic drug maker has to negotiate with the brand firm to enter into a shared REMS programs before the generic drug can be approved. We know that these negotiations between a brand and generic company — to reach agreement on shared system REMS — can extend for long periods of time. This can delay market entry of a generic drug,” Scott Gottlieb, MD, FDA Commissioner, said in today’s statement.

“While the FDA recognizes that these negotiations are an important step in the formation of a shared system REMS, the agency is also committed to making sure that REMS programs maintain their role in serving public health. The REMS shouldn’t become a tool that drug companies can use to delay or block competition from generic products or hinder their ability to enter the market,” he continued.

To that end, Gottlieb said, the agency issued the draft guidances.

The first, “Development of a Shared System REMS,” outlines general principles and recommendations to assist sponsors with developing these programs. According to the FDA, this guidance is intended to enhance the clarity and efficiency of developing shared system REMS, which in turn will allow timelier market entry for products that make up these REMS.

The FDA said the second draft guidance, “Waivers of the Single, Shared System REMS Requirement,” provides details on when and how the FDA will contemplate waiving the single, shared system requirement, and how generic applicants can request such waivers.

Clinicians and other members of the public are encouraged to submit comments on the first guidance within 60 days of June 1, and on the second guidance within 90 days of June 1. Instructions and tips on how to do so can be found within each guidance document.

Gottlieb’s announcement comes on the heels of the release of Trump administration’s plan to overhaul the way the drug prices are set. Among the initiatives the administration announced last month is increased competition to avert manufacturer gaming of regulatory processes such including REMS. Experts Healio Family Medicine spoke to at that time said the plan largely misses the mark, and faces an uphill battle in becoming reality.

A Washington Examiner report earlier this week indicated HHS Secretary Alex Azar, Jr., plans to meet with the Senate Health, Education, Labor and Pensions Committee hosts Health and Human Services Secretary Alex Azar on June 12 to discuss this committe's ideas and the president’s proposals. In addition, a CNBC report quoted the president on May 30 as saying drug companies are going to announce "voluntary massive" price cuts in two weeks.

Stay tuned to Healio Family Medicine for continuing coverage. – by Janel Miller

For more information:

FDA.gov. Development of a Shared System REMS Guidance for Industry. https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM609045.pdf. Accessed May 31, 2018.

FDA.gov. https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM609048.pdf. Waivers of the Single, Shared System REMS Requirement. Accessed May 31, 2018.

Disclosure: Gottlieb is commissioner of the FDA.

Scott Gottlieb
Scott Gottlieb

The FDA released several draft guidances today that it said it hopes will assist generic drug makers get their products through the development and approval process while keeping the agency’s Risk Evaluation and Mitigation Strategy, or REMS, safety controls in place.

“Bringing together multiple products under one REMS program can have real benefits for the health care system, including for providers. But, the generic drug maker has to negotiate with the brand firm to enter into a shared REMS programs before the generic drug can be approved. We know that these negotiations between a brand and generic company — to reach agreement on shared system REMS — can extend for long periods of time. This can delay market entry of a generic drug,” Scott Gottlieb, MD, FDA Commissioner, said in today’s statement.

“While the FDA recognizes that these negotiations are an important step in the formation of a shared system REMS, the agency is also committed to making sure that REMS programs maintain their role in serving public health. The REMS shouldn’t become a tool that drug companies can use to delay or block competition from generic products or hinder their ability to enter the market,” he continued.

To that end, Gottlieb said, the agency issued the draft guidances.

The first, “Development of a Shared System REMS,” outlines general principles and recommendations to assist sponsors with developing these programs. According to the FDA, this guidance is intended to enhance the clarity and efficiency of developing shared system REMS, which in turn will allow timelier market entry for products that make up these REMS.

The FDA said the second draft guidance, “Waivers of the Single, Shared System REMS Requirement,” provides details on when and how the FDA will contemplate waiving the single, shared system requirement, and how generic applicants can request such waivers.

Clinicians and other members of the public are encouraged to submit comments on the first guidance within 60 days of June 1, and on the second guidance within 90 days of June 1. Instructions and tips on how to do so can be found within each guidance document.

Gottlieb’s announcement comes on the heels of the release of Trump administration’s plan to overhaul the way the drug prices are set. Among the initiatives the administration announced last month is increased competition to avert manufacturer gaming of regulatory processes such including REMS. Experts Healio Family Medicine spoke to at that time said the plan largely misses the mark, and faces an uphill battle in becoming reality.

A Washington Examiner report earlier this week indicated HHS Secretary Alex Azar, Jr., plans to meet with the Senate Health, Education, Labor and Pensions Committee hosts Health and Human Services Secretary Alex Azar on June 12 to discuss this committe's ideas and the president’s proposals. In addition, a CNBC report quoted the president on May 30 as saying drug companies are going to announce "voluntary massive" price cuts in two weeks.

Stay tuned to Healio Family Medicine for continuing coverage. – by Janel Miller

For more information:

FDA.gov. Development of a Shared System REMS Guidance for Industry. https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM609045.pdf. Accessed May 31, 2018.

FDA.gov. https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM609048.pdf. Waivers of the Single, Shared System REMS Requirement. Accessed May 31, 2018.

Disclosure: Gottlieb is commissioner of the FDA.

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