Life Science Compliance Update

November 29, 2016

21st Century Cures Update - Includes Exemption for Education in Open Payments

CuresActCongress

When lawmakers head back to Washington, D.C. this week, one of the votes they have ahead of themselves is the 21st Century Cures bill, legislation that is intended to spur the development of new medical treatments. The bill was updated the Friday after Thanksgiving, leaving many of the provisions of previous versions intact, but also adding language intended to improve America’s mental health system and dedicates $1 billion over the course of two years to help combat the opioid epidemic.  

The updated package directs $4.8 billion in funding over a decade to the National Institutes of Health and includes $1.4 billion for President Obama’s Precision Medicine Initiative, $1.8 billion for Vice President Joe Biden’s cancer “moonshot” program, and $1.6 billion for a program focused on enhanced understanding of brain-related diseases like Alzheimer’s. The bill would be paid for mostly through sales of the U.S. strategic petroleum reserve and a fund created in the 2010 health care overhaul intended to promote disease prevention and public health.

The vehicle for the new bill will be existing legislation (HR 34) related to tsunami warning systems. Since the Senate has already passed an amended version of that bill, the package could be sent from the House back to the upper chamber and acted on relatively quickly. The vote is expected to take place on Wednesday, under suspension of the rules, preventing any amendments.

House Energy and Commerce Chairman Fred Upton of Michigan and Senate Health, Education, Labor and Pensions Chairman Lamar Alexander of Tennessee, the two main sponsors of the package, touted the bill as beneficial to virtually every American family. “What we have in the 21st Century Cures Act is an innovation game-changer, a transformational bill to bring our health infrastructure light years ahead to best match the incredible breakthroughs that are happening by the day,” the lawmakers said in a joint statement. “We look forward to swift and favorable consideration of the 21st Century Cures Act in both the House and Senate.”

Sen. Christopher S. Murphy, D-Conn., a vocal supporter of mental health changes, on Sunday released a statement praising the package. “I'm excited Republicans and Democrats have put politics aside and reached a compromise that will allow a mental health reform bill to pass side by side with major new funding to confront the nation's opioid crisis. Both parties needed to make concessions to get this deal done, but the deal that has been struck is good for patients and families. I hope we get it done,” Murphy said.

Key Provisions of the Bill

Measures related to the FDA largely remain intact from the previous House-passed bill. The biggest change is the addition of language to help speed the development of regenerative medicine, or treatments that are designed to help regrow damaged cells or tissues. Such a provision would give the FDA the ability to put some of these treatments through what’s known as “accelerated approval,” a pathway that allows companies to conduct clinical trials on smaller populations and requires follow-up studies once the drug is on the market.

The $1 billion to curb painkiller abuse would effectively grant President Obama’s budget request from February. Included in the funding is a bid to gather support from Democrats, as well as an acknowledgement that this year’s stalled appropriations process would not be adequate for funding the opioid response envisioned by the backers of an opioid abuse package signed into law this summer.

The bill’s section on mental health would make changes to the leadership structure at the Substance Abuse and Mental Health Services Administration and establish/reauthorize grants for state and community mental health services. It would give HHS tools to enhance compliance with parity laws, which require insurers that cover mental health to offer mental health benefits that are as valuable as other medical coverage.

The most notable additions are aspects of a bill from Sen. John Cornyn (S. 2002). Those provisions would offer grants to law enforcement and the judicial system to improve their capacities to deal with mental health problems. Lawmakers wound up dropping controversial language from Cornyn’s bill that would have restored gun rights to certain individuals who had been committed for mental health treatment.

The legislation also changes policies governing electronic medical records by directing the federal government to issue a voluntary model framework on the sharing of patients' health information, and creates a grant program to help develop a reporting system that would provide the government with more information about the use and security of electronic health records.

Open Payments

Inserted into the legislation is a provision from Congressman Defazio, Burgess, and Senator Barrasso to exempt applicable manufacturers from reporting payments made for continuing medical education sessions, medical journals, or textbooks. We tend to believe that the reporting requirements stifle access to important information and have a detrimental effect on continuing medical education (CME) programming.

This represents a smart tweak to the current regulation.  Unlike the other categories under Open Payments, education represents the free exchange of ideas.

“This is about patient care — doctors need good information fast and this facilitates the process,” said John Kamp, who heads the Coalition for Healthcare Communication, a group of ad agencies and medical publishers. “I want my doctors to have information about whatever the latest science is saying.” He noted that the Food and Drug Administration is currently weighing rules for allowing companies to distribute information to physicians about unapproved uses of medicines.

September 19, 2016

New Rule and Guidance Issued on Clinical Trials

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Clinical trials are one of the most visible components of the biomedical research field, in part due to the way they directly engage human participants. Clinical trials have done a lot of good, providing advances in diagnosis, treatment, and prevention, but there are still large challenges. As such, changes are always needed to reflect science and society’s movement to increase efficiency, accountability, and transparency in clinical research.

Health and Human Services Final Rule

In an effort to make information about clinical trials more widely available to the public, the United States Department of Health and Human Services (HHS) issued a final rule that specifies requirements for registering certain clinical trials and submitting results information to ClinicalTrials.gov. The final rule expands the legal requirements for submitting registration and results information for clinical trials that involve drug, biological, and device products regulated by the Food and Drug Administration (FDA).

The requirements found within the rule generally apply to the “responsible party,” typically the sponsor of the clinical trial or designated principal investigator. The rule lays out a process for determining who the rule applies to, and which studies are considered “applicable clinical trials.”

Requirements under the final rule apply to most interventional studies of drug, biological and device products that are regulated by the FDA. The requirements do not apply to phase 1 trials of drug and biological products, or small feasibility studies of device products. The final rule also specifies how and when information collected in a clinical trial must be submitted to ClinicalTrials.gov. It does not, however, dictate how clinical trials should be designed or conducted, or what data must be collected.

Responsible parties must register their trial within twenty-one days of enrolling the first participant. The rule includes specific data elements that are to be submitted upon registration. Additionally, if the product studied is available via expanded access (when a product is used outside of a clinical trial, before it is FDA approved), the responsible party shall submit information about how patients can get access to that product.

Results information from applicable clinical trials shall generally be submitted within one year after the trial’s primary completion date. Submission of results information may be delayed, in certain circumstances, for up to two additional years for trials of products regulated by the FDA that are unapproved, unlicensed, or uncleared.

The type of information submitted will consist of “tables of information summarizing: 1) participant flow information, 2) demographics and baseline characteristics of the enrolled participants, 3) primary and secondary outcomes, including results of any scientifically appropriate statistical tests, and 4) adverse events.” As part of adverse events information there will be a table for all-cause mortality. The information will be submitted in aggregate, with no personally identifiable information. The rule requires responsible parties to update the information annually.

The final rule will be effective January 18, 2017. As of that date, ClinicalTrials.gov will allow responsible parties to comply with the rule; there is a ninety-day grace period for responsible parties to come into compliance with the requirements of the rule.

National Institutes of Health Policy Guidance

The National Institutes of Health (NIH) is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is the largest public funder of clinical trials in the United States. With such investment comes great responsibility. As such, NIH must work to ensure supported trials: investigate a mission-relevant question of high priority, do not duplicate previously conducted trials that do not need replication, and have the highest likelihood to advance knowledge and improve health.

NIH has launched a new effort to improve the quality and efficiency of clinical trials. These initiatives will reengineer the process by which clinical investigators develop ideas for new trials, how NIH reviews and selects clinical trials for support and oversees the progress of the research, and how results and aggregate data are shared broadly and rapidly.  

As part of the aforementioned initiatives, NIH issued a policy on the same day as the HHS final rule, in an attempt to promote broad and responsible dissemination of information from NIH-funded clinical trials through ClinicalTrials.gov. The policy establishes the expectation that investigators that conduct clinical trials funded at all by NIH will ensure that the trials are properly registered and that results information of the trials are submitted to ClinicalTrials.gov.

The policy, similar to the rule, requires applicable clinical trials to be registered in ClinicalTrials.gov no later than twenty-one calendar days after the enrollment of the first participant.

Applicants and offerors seeking NIH funding will be required to submit a plan for the dissemination of NIH-funded clinical trial information that will address how expectations contained within the policy will be met.

The new NIH policy applies to all NIH-funded trials, including phase 1 clinical trials of FDA-regulated products and small feasibility device trials, as well as products that are not regulated by the FDA, such as behavioral interventions.

The policy will take effect January 18, 2017. Failure to comply with the terms and conditions of the policy may result in enforcement actions, including termination.

FDA and NIH Comments

“When people participate in clinical trials, they are volunteering to create generalizable knowledge to help others in the future and we want their participation honored by ensuring that the existence of trials and their results are available to all patients and their healthcare providers, as well as researchers,” said FDA Commissioner Robert M. Califf, M.D. “The FDA will help ensure compliance with these new requirements so that patients and providers can have confidence in and access to significantly more clinical trial information, and researchers can improve clinical trial focus and design.”

“Access to more information about clinical trials is good for patients, the public and science,” said NIH Director Francis S. Collins, M.D., Ph.D. “The final rule and NIH policy we have issued today will help maximize the value of clinical trials, whether publicly or privately supported, and help us honor our commitments to trial participants, who do so much to help society advance knowledge and improve health.”

A summary table of both the final rule and new guidelines can be found here.

May 26, 2016

NIH Asks for Input on NCAB Cancer Moonshot Blue Ribbon Panel

Recently, the National Institutes of Health (NIH) released a Request for Information (RFI), asking for both public and cancer research community input on the National Cancer Advisory Board (NCAB) Blue Ribbon Panel. The Blue Ribbon Panel is part of the National Cancer Moonshot Initiative, which is led by Vice President Joe Biden and aims to make more cancer therapies available, while continuing to improve cancer prevention and early detection. Additional details of the National Cancer Moonshot Initiative can be found at http://www.cancer.gov/research/key-initiatives/moonshot-cancer-initiative.

The purpose of the NCAB is to ensure that the National Moonshot Initiative's goals and approaches are grounded in solid science. The Blue Ribbon panel is a panel of experts assembled to guide the NCAB's work and is composed of leading experts from a broad range of scientific areas including biology, immunology, genomics, diagnostics, bioinformatics, and cancer prevention and treatment. The panel does not just include researchers, however, it also includes clinicians and nurses, as well as representatives of cancer advocacy organizations and the pharmaceutical and biotechnology industries.

NIH is seeking community input to help "enable the Blue Ribbon Panel to consider a wide range of input from researchers, scientists, physicians, advocates, students, data scientists, and members of the public." They are requesting input in the following specific areas: expanding clinical trials; enhanced data sharing; cancer immunology and prevention; implementation sciences; pediatric cancer; precision, prevention, and early detection; and tumor evolution and progression.

The request for information is for planning purposes only and should not be construed as a solicitation for applications or proposals, or as an obligation on the part of the United States federal government.

If you have any questions about this particular RFI, you can contact Kelli Marciel at the National Cancer Institute at 9609 Medical Center Drive, Bethesda, MD 20892-9760, kelli.marciel@nih.gov, or (301) 594-3330.

NIH is asking for responses to be submitted to either the National Cancer Institute (NCI) or NIH before July 1, 2016 at 5:00 pm EST. Responses can be submitted electronically through the online platform or via email to cancerresearch@nih.gov. While electronic responses are preferred, non-electronic responses can be accepted by calling the NCI Cancer Information Service at (800) 422-6237, or by mail to Blue Ribbon Panel, National Cancer Moonshot Initiative, National Cancer Institute, 9609 Medical Center Drive, Bethesda, MD 20892-9760.

 

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