Life Science Compliance Update

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August 03, 2017

US Senate Passes FDA User Fees, Right to Try and Opioid Legislation

Senate Floor
After many months of debate, both chambers of Congress passed the FDA User Fee Package. This comes after the Senate passed its bill (S. 934) which cleared the Senate HELP Committee in May on a bipartisan basis. The House passed its bill on July 13 (H.R. 2430). The FDA Reauthorization Act (FDARA) renews and enhances the FDA drug, medical-device, biosimilar, and generic-drug user-fee provisions. The bill was uniquely tied to “Right to Try” legislation, and the Senate also passed bipartisan legislation on the opioid epidemic.

Senate FDARA Bill

The politics of the bill were intricately locked in with another member of the Senate’s own legislation. Majority Leader Mitch McConnell (R-KY) committed to taking up an amended version of Sen. Johnson’s right-to-try legislation to the floor in a separate vote, which cleared the way for Senate consideration of the user fee package.

FDA Commissioner Scott Gottlieb informed agency employees via email on July 24th that he would not be sending out any layoff notices to user fee-funded staff “unless and until September 30 had passed without reauthorization.” The publicizing of this policy decision by the Commissioner may have been intended to signal to the Senate that the sky is not falling (yet), but that they need to get to work.

"This program is critical to speeding up the drug approval process, and that's important for everyone frustrated by the time and cost of bringing life-saving drugs to market," McConnell said in floor remarks on FDARA. "Without it, the important work of ensuring that drugs and devices are safe and effective would come to a screeching halt."

User Fees

Specifically, the FDA Reauthorization Act of 2017 addresses several aspects of the FDA’s user-fee provisions:

Prescription Drug User Fee Amendments of 2017

The bill amends the Federal Food, Drug, and Cosmetic Act to extend through FY2022 and revise Food and Drug Administration user fees for new drug applications. User fees are eliminated for supplements to new drug applications and drug manufacturing facilities.

Medical Device User Fee Amendments of 2017

The bill extends through FY2022 and revises FDA user fees for medical devices. A user fee is established for requests to classify devices that are not substantially equivalent to marketed devices. The FDA is no longer granted the discretion to waive or reduce fees in the interest of public health. The FDA must establish a pilot program to accredit testing laboratories to determine whether medical devices conform to performance standards. The bill also revises the types of medical devices that the FDA may accredit third parties to review.

Generic Drug User Fee Amendments of 2017

The bill extends through FY2022 and revises FDA user fees for generic drugs. User fees are eliminated for supplements to generic drug applications. An annual fee is assessed on holders of approved generic drug applications.

Biosimilar User Fee Amendments of 2017

The bill extends through FY2022 and revises FDA user fees for biosimilars. (Biosimilars are biological products approved by the FDA based on their similarity to an already-approved biological product.) User fees are eliminated for supplements to biosimilar applications and biosimilar manufacturing facilities. An annual fee is assessed on holders of approved applications for biosimilars. The bill sets the annual amount of revenue that must be generated by fees. The bill also extends through FY2022 programs and policies including Critical Path Public-Private Partnerships and support for development of medical products for rare conditions.

Industry Supported

The House and Senate language is very similar, and the House bill was widely supported by industry when it passed in July: “This legislation ensures that the FDA continues to have the resources necessary to carry out its critical human drug review programs, while advancing important patient-centered policies that will help streamline the clinical trial process—the most time-consuming, complex, and expensive step in the drug development process. It also takes important steps to advance patient involvement in drug development and bring patient perspectives more clearly to bear on regulatory decisions. The reauthorization of the biosimilars user fee program, including steps to improve communication throughout application review, will move the needle on getting more affordable biosimilar products to patients in a timely way, once the IP protection expires for new biologics,” BIO President and CEO James C. Greenwood said in a statement.

PhRMA president and CEO Stephen J. Ubl issued the following statement: “Timely reauthorization of the Prescription Drug, Biosimilar and Generic Drug User Fee Acts is crucial to patients in need of life-saving treatments and enhancing the competitive market in biopharmaceutical innovation. The House took an important step in reauthorizing the user fee programs and we look forward to swift action in the Senate on behalf of America’s patients.”

Right To Try

Sen. Ron Johnson's Trickett Wendler, Frank Mongiello and Jordan McLinn Right to Try Act of 2017 (S. 204 (115)) authorizes the use of unapproved medicines by patients diagnosed with a life-threatening illness as long as the drugs in question have already been tested in the first phase of human clinical trials and are continuing on in further FDA-overseen research. Patients must have exhausted other treatment options and be unable to participate in ongoing clinical trials. Reps. Andy Biggs and Brian Fitzpatrick have a similar bill pending in the House.

Johnson's measure aroused concern from the drug industry, public health advocates and some at the FDA. But Johnson threatened to hold up the reauthorization of the FDA user fee programs if he did not get a vote on the bill. A compromise reached by Senate leadership and leaders of the Senate HELP Committee gave Johnson a vote on a revised version of his bill, separate from the FDA user fee bill. The compromise included requiring the FDA to receive reports of safety events that occur in right-to- try situations and forbids patients from being charged more than the cost of production for the medicines.

Opioids

Additionally, lawmakers passed a bipartisan opioids bill (S. 581), from Sen. Joe Manchin (D-WV), requiring HHS to develop standards for hospitals and physicians to denote a patient's history of opioid addiction in medical records. The legislation directs the FDA to develop standards that: (1) consider the potential for addiction relapse or overdose death if a patient recovering from addiction is prescribed opioids; (2) require that a history of opioid addiction be displayed in a manner " similar to other potentially lethal medical concerns" such as drug allergies; and (3) require medical professionals have access to the opioid information to ensure they can prescribe medically appropriate medication.

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