Life Science Compliance Update

October 16, 2015

FDA Establishes the Patient Engagement Advisory Committee


There has been a surge in the development of new medical technologies over the last couple of decades. When looking at the way these developments have come about, it may seem odd when one realizes that these were largely developed based on expert opinions, not by asking patients and families directly what they consider most important.

That way of thinking is slowly starting to change and become more “patient-centered.” Patients, their physicians, and other care partners are beginning to actively participate in the decision-making and priority-setting about all aspects of their health care, and this is starting to have an impact on the medical industry. 

According to Nina L. Hunter, Ph.D., and Robert M. Califf, M.D., Americans are becoming more active consumers of health care by making decisions about their doctors, diagnostics, treatments, and health care experiences instead of allowing their health care providers to make those decisions for them.

In an effort to adjust to this new “patient-centered” thinking, the Food and Drug Administration has recently announced their establishment of the Patient Engagement Advisory Committee (PEAC). The PEAC will be responsible for advising the commissioner of the FDA “on complex issues relating to medical devices, regulation of devices, and their use by patients.” The PEAC will aim to “improve communication of benefits, risks, clinical outcomes, and increase integration of patient perspectives into the regulatory process for medical devices.”

The PEAC will have nine voting members who are selected by the Commissioner and should be knowledgeable in different areas, such as clinical research, primary care patient experience, and health care needs of patient groups throughout the United States. Members of the PEAC will be invited to serve terms up to four years and almost all non-Federal members of the committee will serve as Special Government Employees.

The FDA is soliciting feedback on topics for the PEAC to discuss and advise the Agency. Some topics the FDA is planning for the PEAC to cover are: where can patients provide input across the medical device total product lifestyle?; how should FDA directly engage patients for input related to medical device premarket considerations?; how should FDA engage patients for input related to medical device performance once products are available on the market?; and how should sponsors present patient preference information or PROs in the health care professional and patient labeling?

 The FDA has opened a docket for public comment on the potential topics, which will remain open through November 20, 2015. Additionally, the FDA is soliciting nominations for voting members, which must be received by November 20, 2015 and nominations for the voting consumer representative and a pool of nonvoting industry representatives, both of which must be received by October 21, 2015.

The FDA is looking forward to working with others to help advance the science of patient input and believe that their focus on patient-centered technology development, evaluation, and use has already started to positively affect the development of innovative therapies and clinical solutions. 

October 14, 2015

FDA Notice of PDUFA Reauthorization – Public Comments due April 29, 2016


The Food and Drug Administration has issued a notice that they are reopening the comment period for interested parties to submit feedback on the Prescription Drug User Fee Act (PDUFA) reauthorization. This comment period pertains to the notice of public meeting published May 13, 2015 (80 FR 27323).

The Prescription Drug User Fee Act authorizes the FDA to collect user fees for the process for the review of human drugs and the current legislative authority for PDUFA expires in September 2017. At that time, new legislation will be required for the FDA to be permitted to continue collecting user fees. PDUFA’s intent is to provide revenues to the FDA so the FDA can hire additional staff, improve systems, and establish a better managed human drug review process, which will in turn make important therapies available to patients sooner without compromising review quality. 

Variations of PDUFA have been around since 1992 and have made significant strides in reviewing original new human drug and biological product applications, resubmissions of original applications, and supplements to approved applications. The FDA has maintained their high standards for safety, efficacy, and quality while eliminating backlog and allowing authorized drugs on the market in an efficient manner, benefitting patients nationwide.

The FDA held a meeting on July 15, 2015, and received a wide variety of comments on a range of topics. Some of the topics discussed were: the assessment of the overall performance of PDUFA V (current PDUFA) thus far; what current features of PDUFA should be reduced or discontinued to ensure the continued efficiency and effectiveness of the human drug review process; and what new features should FDA consider adding to the program to enhance the efficiency and effectiveness of the human drug review process.

The comment period will be open until April 29, 2016 “to allow interested persons additional time to submit comments.” Interested persons may submit either electronic or written comments. 

For further information, contact Graham Thompson, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 1146, Silver Spring, MD 20993-0002, (301) 796-5003. 

September 18, 2015

White House Nominates Robert Califf As The Next FDA Commissioner


President Barack Obama has nominated the Food and Drug Administration's Dr. Robert Califf, the current Deputy Commissioner for Medical Products and Tobacco, to lead the agency (see the White House announcement). Dr. Califf joined the FDA as deputy commissioner earlier this year after more than 30 years at Duke University and is a recognized global leader in cardiology and clinical research. His nomination to head the agency was expected after former commissioner Dr. Margaret Hamburg announced she would step down shortly after appointing Califf to Deputy Commissioner.

Stephen Ostroff, previously the FDA's chief scientist, has served as acting commissioner over the last six months.

In coming to FDA, Dr. Califf left his post as the director of the Duke Translational Medicine Institute (DTMI). He founded the Duke Clinical Research Institute (DCRI), the largest academic research organization in the world. Under his leadership, DCRI grew to 1,000 employees with an annual budget of $100 million, notes David Kroll of Forbes. Furthermore, Hamburg stated in her appointment of Califf back in Januaray that “Dr. Califf is recognized by the Institute for Scientific Information as one of the top 10 most cited medical authors, with more than 1,200 peer-reviewed publications.”

The reaction to Califf’s nomination has been positive.

“Robert Califf Could Transform The FDA – The Right Way” (Forbes): “Whoever winds up running the country after the next election would be wise to keep Califf at the FDA’s helm. He could handle either situation.”

"Califf Nomination for FDA Chief Gets Mostly High Marks--But ties with industry may be an issue" (MedPage Today). This article lists a wide range of health policy and cardiology experts who weighed in very positively on Califf’s nomination. For example, MedPage Today quotes Sanjay Kaul, MD, MPH, of Cedars-Sinai Heart Institute in Los Angeles, who wrote: "I can't think of a more qualified person than Dr. Califf to lead the FDA at the present time…He is an accomplished leader in cardiovascular disease research whose work has resulted in therapies that save lives and improve the quality of life for millions of patients."

In terms of how much change Califf would bring to the agency, the article quoted Steve Nissen, MD, chair of cardiovascular medicine at the Cleveland Clinic: "He's not going to sit on his hands…This is a guy who's going to make changes."

Importantly, Califf could be heading the agency at a significant time. The 21st Century Cures Act, recently passed by the House and awaiting Senate approval, outlines numerous changes seeking to streamline the drug approval process.

As the title of the Medpage Today article notes, some have been critical of Califf’s ties to industry, including Public Citizen and a Time article published in February entitled “Candidate to Lead FDA Has Close Ties to Big Pharma.” However Califf’s extensive experience clearly has had a positive impression on the Obama administration. Califf noted that collaboration between industry, academia, and government is vital. “The greatest progress almost certainly will be made by breaking out of insular knowledge bases and collaborating across the different sectors,” Califf says, as quoted in Time. There is “a tension which cannot be avoided between regulating an industry and creating the conditions where the industry can thrive, and the FDA’s got to do both.” Califf added it would be “useful to have someone [leading the FDA] who understands how companies operate because you’re interacting with them all the time.”

Further, Larry Husten of CardioBrief was critical of Public Citizen's call for the senate to reject Califf's nomination. "I think Public Citizen is mistaken, though it is certainly true that Califf has worked closely with industry throughout his career," Husten writes. "But if you’ve paid careful attention to his words it’s clear that Califf’s primary goal has never been to serve industry." He goes on to say that "I think [Califf] is interested in finding ways to use the enormous resources of industry to develop new therapies."



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