Life Science Compliance Update

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.

July 18, 2017

United States House of Representatives Passes PDUFA

Lg_PDUFA_VI

On Wednesday, July 12, 2017, the United States House of Representatives passed a bill via voice vote to reauthorize the prescription drug, generic drug, medical device and biosimilar user fee programs through 2022.

The current user fee programs expire September 30th, though the United States Food and Drug Administration (FDA) has said that if the reauthorization bill is not signed by President Donald Trump before August 1st, the FDA will be forced to send out layoff notices to about 5,000 employees.

“This legislation will save lives,” Representative Greg Walden said on the House floor, noting he thinks the Senate will adopt the bill, as well.

In addition to reauthorizing the user fee programs, the bill contains several new directives for the FDA, including provisions requiring quicker reviews of some generic drugs and changes in how the agency will conduct medical device inspections. The FDA will also be instructed to work on expanding clinical trial criteria so more patients can be eligible for experimental medicines. The bill is expected to cut the time it takes the agency to approve new treatments.

The House added more than a dozen new sections to the bill ahead of the vote, including sections aimed at curbing abuse of the orphan drug designation and policies designed to speed generic drug approvals. Most of the new elements of the House bill were added to align the chamber's legislation with the version passed out of the Senate HELP Committee. The House bill added a new title focused on pediatric drugs and devices that would allow the FDA to require adult cancer drugs that share a common target with a pediatric cancer to be studied in children starting in 2020. Other new elements of the bill clarify when pediatric information can be left off a drug's label to speed access to generic medicines, and new sections mandating that FDA review generic drug applications within eight months if the brand drug patents have expired and the treatment has three or fewer approved competitors on the market.

Several sections of the bill were removed ahead of the vote, including provisions altering the notification requirements for FDA related to laboratory developed tests, requiring FDA to issue guidance on how to demonstrate bioequivalence to a reference drug to facilitate generic development, a section on information technology contracting, and legislation designed by industry and the FDA to create an over-the-counter monograph.

Senate Reaction

The Senate has yet to schedule a floor debate and vote on its version of the user fee bill. Senate Lamar Alexander said Wednesday that it's now time for the full Senate to consider these bipartisan user fee agreements.

Senate Majority Leader Mitch McConnell (R-KY) has stated, “It’s an extremely important bill that I think we’ll be able to move on a bipartisan basis.” And ranking member Patty Murray (D-WA) pledged a “bipartisan and non-controversial” user fee bill, highlighting the necessity of similar legislation.

However, Senator Ron Johnson also said Wednesday that he will try to delay the bill unless it includes language related to the “Right-to-Try” legislation, which undercuts FDA and has been sweeping across states. A nonpartisan report issued Tuesday notes that issues with expanded access are not linked to FDA regulations.

The Congressional Budget Office says it expects the FDA to collect roughly $9 billion in fees—$8 billion for drugs and $1 billion for devices—between 2018 and 2022, based on the fee level set in the Senate bill.

Industry Reaction

FDA Commissioner Scott Gottlieb, MD, praised the passage of the bill in the House on Twitter:

Capture

Pharmaceutical Research and Manufacturers of America (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.

April 27, 2017

Senate HELP Hearing on FDA User Fee

JanetWoodcock_AP_867908183231-1024x576

On March 21, the Senate Health, Education, Labor, and Pensions (HELP) Committee held a hearing on Food and Drug Administration (FDA) user fee agreement reauthorizations. In the first of two expected hearings, senators discussed the ability of the user fee agreements to improve medical product regulation and advance initiatives laid out by the 21st Century Cures Act passed in the last Congress. On a broader level, there are four different user fees that are the subject of hearings and must be updated and reauthorized by Congress. This includes the prescription drug user fee act (PDUFA), the medical device user fee amendments (MDUFA), the generic drug user fee amendments (GDUFA), and the biosimilar user fee act (BsUFA).

Participants

At the hearing included FDA’s Janet Woodcock, Director for the Center for Drug Evaluation and Research; Peter Marks, Director of the Center for Biologics Evaluation and Research; and Jeffrey E. Shuren, Director of the Center for Devices and Radiological Health. Chairman Alexander announced a second hearing on user fees would be held April 4, during which patients, device manufacturers, and brand and generic drug manufacturers are expected to testify.

Selected Opening Statements

Chairman Lamar Alexander opened the hearing by thanking the committee for working together in the past to advance important legislation such as the 21st Century Cures Act. He asked that the Committee work together again to advance the reauthorization of user fee agreements “to ensure that the policies laid out in the 21stCentury Cures Act to support innovative medicines and therapies are not delayed by the drug approval pipeline.” […] The sooner we reauthorize the agreements, the better – to give patients, reviewers and companies certainty,” he said. Chairman Alexander also warned that any bills being added to user fee reauthorizations must be bipartisan and non-controversial to ensure the user fees are reauthorized before adverse effects are triggered. Patty Murray (D-WA) began by reminding Chairman Alexander of the letter sent to him and signed by every Democrat on the Committee asking that the hearing be delayed to instead discuss the healthcare bill currently moving through the House of Representatives.

Selected Testimony

Dr. Woodcock indicated that the FDA user fees are responsible for fast and predictable review of innovative therapies for Americans, and ensure these therapies are available first in the United States. She reminded the Committee that prescription drug user fees have brought many cures to the market recently. Dr. Marks stated the user fees fund the Center for Biologics Evaluation and Research have advanced necessary public health initiatives such a vaccine development, approval, and distribution. He spoke to the importance of the applications of biologics, and the ability of regenerative medicine to meet currently unmet medical needs. Dr. Jeffrey E. Shuren affirmed that the user fee programs are much different from the last time he testified before the Committee. He declared that the Center for Devices and Radiological Health has gone beyond their three commitments under the medical device user fee program, and now approve innovative technology in record time.

Discussion

During the hearing, many Democrats used their time to express their disapproval for the timing of the hearing, which they argued should have been delayed to make way for discussion on the AHCA. For example. Sen. Elizabeth Warren (D-MA) grew frustrated when witnesses refused to respond to her questions regarding President Trump’s budget proposal. The Senator questioned whether budget cuts to the FDA would make it harder for the agency to operate, to which witnesses responded they were not in any position to discuss budgetary matters. 

The hearing also offered little discussion of President Trump’s proposal to double industry user fees to fully pay for premarket approvals. Although most senators were quick to praise the user fee program, Sen. Richard Burr (R-NC) grilled witnesses on how the funding earned from user fees was spent. He asked several questions that suggested user fee funds were misspent, and even asked the witness if they thought the fees should be returned to manufacturers if they do not believe their agreement with the FDA was fulfilled.

Sen. Susan Collins (R-ME) noted during the hearing she will seek to add a Risk Evaluation and Mitigation Strategy (REMS) bill to a user fee reauthorization during markup. She asserted that certain brand pharmaceutical abuse the REMS system by preventing generic competitors from gaining access to drug samples for studies. Dr. Woodcock noted that FDA has notified the Federal Trade Commission about 150 times that pharmaceutical companies are using REMS to delay generics, but said that FDA itself cannot force companies to give branded drugs to generic manufacturers for studies.

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