Life Science Compliance Update

February 02, 2018

FDA REMS Blueprint on Opioids Finalized


On January 30, 2018, the United States Food and Drug Administration (FDA) finalized the “Opioid Analgesic REMS Education Blueprint for Health Care Providers Involved in the Treatment and Monitoring of Patients with Pain.” The Blueprint includes educational messages for health care providers involved in the treatment and monitoring of patients with pain. It also includes information on pain management, including the principles of acute and chronic pain management; non-pharmacologic treatments for pain; and pharmacologic treatments for pain (non-opioid analgesic and opioid analgesic).  This REMS represents a major upgrade from the current ER-LA Opioid REMS and includes all Opioid Manufacturers.

Ever since the Opioid Policy Steering Committee was established the FDA has been working to evaluate different policy efforts to combat the emergency. According to FDA Commissioner Dr. Scott Gottlieb, “At the FDA, we believe one of our key roles in addressing the opioid epidemic is to reduce new addiction. We’re exploring ways we can reduce exposure to opioids through our influence on prescribers, particularly through our Risk Evaluation and Mitigation Strategy (REMS) authorities. We’re also actively exploring how we can use changes in packaging as a way to give providers better options for tailoring how much they prescribe to the clinical need. This is especially true when it comes to immediate release formulations of opioid drugs like Vicodin and Percocet, which are typically meant for short-term use.”

The Blueprint aims to educate health care providers on safe opioid practices, as well as current Federal and state regulations, national guidelines, and professional organization and medical society guidelines on treating pain and prescribing opioids.

The Blueprint begins with an overview on pain management, including intelligence behind the need for comprehensive pain education, definitions and mechanisms of pain, and how to assess patients in pain.

From there, it goes on to help providers learn how to create a pain treatment plan, customized to the needs of the individual patient and including the types of therapies planned, the goals of treatment, and an explanation of the patient and prescriber roles and responsibilities. It further notes that if HCPs encounter potential barriers to managing patients with pharmacologic and/or nonpharmacologic treatment options, such as lack of insurance coverage or inadequate availability of certain HCPs who treat patients with pain, attempts should be made to address these barriers. The overall treatment approach and plan should be well documented in the patient record, including written agreements and informed consent/patient provider agreements that reinforce patient-provider responsibilities and avoid punitive tones.

The section about creating a pain treatment plan includes sections that outline: components of an effective treatment plan, general principles of nonpharmacologic approaches, general principles of pharmacologic analgesic therapy, managing patients on opioid analgesics, and a primer on addiction medicine.

FDA is making the FDA Blueprint, which will be approved as part of the Opioid Analgesic REMS, available on the REMS@FDA Website (, where it will remain posted for use by CE providers as they develop the CE materials and activities. A list of the REMS-compliant CE activities supported by unrestricted educational grants from the opioid analgesic companies to accredited CE providers will be made available when the Opioid Analgesics REMS is approved.

Other FDA Actions

On the same day the FDA released the new Blueprint, the Agency also hosted a meeting entitled, “FDA’s Opioid Policy Steering Committee – Prescribing Intervention – Exploring a Strategy for Implementation,” where various stakeholders spoke about the Agency’s Risk Evaluation and Mitigation Strategy (REMS) authority and how to improve safe use of opioid analgesics.

In the Press Announcement that accompanied these moves by the FDA, Commissioner Gottlieb wrote, “I believe anyone who is distributing health care products has an obligation to be a partner in helping address the most pressing public health challenges like opioid abuse. If you’re selling a drug with the potential for abuse and misuse through an online website, you’re no longer in the business of selling widgets, or books. You have a social contract to take voluntary steps to help address public health challenges.”

Gottlieb encouraged stakeholders to participate in this ongoing process by submitting electronic or written comments to the docket until March 16, 2018.

February 01, 2018

State of the Union De-Briefing


President Donald Trump gave his second State of the Union address this week, and while reactions to his speech were mixed, he mentioned several items of importance to the healthcare space.

Affordable Care Act

First, he noted the repeal of the individual mandate found in the Affordable Care Act, by noting, “We eliminated an especially cruel tax that fell mostly on Americans making less than $50,000 a year -- forcing them to pay tremendous penalties simply because they could not afford government-ordered health plans. We repealed the core of disastrous Obamacare -- the individual mandate is now gone.”

Interestingly to some of his most ardent fans, however, the President did not call for the repeal of the Affordable Care Act in its entirety. Therefore, it seems as though his focus on the ACA will be muted with respect to the rest of the ACA that is still in place, including the Medicaid expansion and other reforms.

Right to Try

President Trump also noted his belief in right to try laws, stating, “We also believe that patients with terminal conditions should have access to experimental treatments that could potentially save their lives. People who are terminally ill should not have to go from country to country to seek a cure -- I want to give them a chance right here at home. It is time for the Congress to give these wonderful Americans the ‘right to try.’”

Vice President Mike Pence has long held Right to Try as a priority of his, and Trump’s call on Congress to pass legislation comes amid stalled House legislation, which easily passed the Senate in August.

More than half of the states have laws that already exist to allow some patients access to experimental treatments and the Food and Drug Administration also hash a pathway that grants expedited access to treatment to patients with terminal illnesses; however, FDA Commissioner Scott Gottlieb has been reluctant to expand much past that.

Opioid Abuse

Many Senators and Congresspeople wore purple ribbons in an attempt to highlight the opioid crisis. President Trump addressed this hot-button issue as well, saying, “In 2016, we lost 64,000 Americans to drug overdoses: 174 deaths per day. Seven per hour. We must get much tougher on drug dealers and pushers if we are going to succeed in stopping this scourge. My Administration is committed to fighting the drug epidemic and helping get treatment for those in need.”

As we have previously written, President Trump has always placed a priority on resolving opioid abuse, including creating a Task Force to review the situation and craft a plan of action. However, he has yet to propose new funding to help states respond (one of the suggestions we often hear from Democrats).

Newly appointed Health and Human Services Alex Azar recently highlighted the administration’s five-point strategy, including (1) encompassing better treatment, prevention, and recovery services; (2) better targeting of overdose-reversing drugs; (3) better data on the epidemic; (4) better research on pain and addiction, and (5) better pain management. Funding for treatment will continue to be central to the debate, and it remains to be seen whether Congress will provide the boost that many public health advocates have been calling for.  

Drug Pricing

Prescription drug prices were a hot topic in the 2016 Presidential election and were, naturally, mentioned during the State of the Union as well. President Trump stated, “To speed access to breakthrough cures and affordable generic drugs, last year the FDA approved more new and generic drugs and medical devices than ever before in our history... One of my greatest priorities is to reduce the price of prescription drugs. In many other countries, these drugs cost far less than what we pay in the United States. That is why I have directed my Administration to make fixing the injustice of high drug prices one of our top priorities. Prices will come down.”

Given the political climate, little action has been seen on this front while excessive rhetoric continues to be the modus operandi of the political class.


Overall, there were statements by the President that earned cheers and some jeers from both sides of the political aisle. While lip service can be effective in providing a motivating speech, we will have to wait to see what changes are actually effectuated in the future.


January 22, 2018

E&C Health Subcommittee Votes to Advance Allowing Truthful Off Label Communication


Immediately before the government shutdown, the Energy and Commerce Health Subcommittee held a markup to advance three health care bills, including a measure designed to give drug and medical device companies more freedom to discuss off-label information, one that would overhaul how the Food and Drug Administration (FDA) regulates over-the-counter (OTC) drugs, and another that would shield a health care professional from liability related to “an act or omission” that occurs as a volunteer in response to a disaster.

Opening Statements

Opening statements were provided by E&C Committee Chairman Greg Walden, E&C Committee Ranking Member Frank Pallone, Jr., and Health Subcommittee Chairman Michael C. Burgess, M.D.

E&C Chairman Greg Walden briefly summarized each of the bills, beginning with H.R. 1876, the Good Samaritan Health Professionals Act, which provides limited liability protections for health practitioners providing care to those in a federally declared disaster, such as the recent wildfires in Oregon and the West or even in a horrific event such as the Boston Marathon bombing.

He then spoke about the Pharmaceutical Information Exchange (PIE) Act of 2017, H.R. 2026. This bill attempts to facilitate communication between medical product developers and payors prior to FDA approval, based on the clinical data those developers will rely on for FDA approval.

Lastly, the Committee discussed the “Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018” legislation that attempts to “modernize the arcane process by which over-the-counter (OTC) health products are made available to consumers.” Walden noted that the OTC Monograph was established over forty years ago and it still remains incomplete today.

He closed by encouraging bipartisan support for these “critical bills.”

Volunteer Liability Protection

The Good Samaritan Health Professionals Act of 2017 (H.R. 1876), introduced by Representative Marsha Blackburn, was passed by voice vote. Full passage of the bill would shield health care professionals who serve as volunteers and believe in “good-faith” an individual is in need of health care services for which they are certified to perform. Health care professionals are not currently protected under the Volunteer Protection Act, passed in 1997. The bill’s liability protections do not apply to health care professionals who cause harm through willful or criminal misconduct, or who perform health care services while under the influence of alcohol or drugs.

Off-Label Communications

The Pharmaceutical Information Exchange (PIE) Act of 2017 (H.R. 2026), sponsored by Representative Brett Guthrie, amends the Federal Food, Drug, and Cosmetic Act (FD&C Act) to allow information about an alternative use for FDA-approved pharmaceuticals and devices to be provided to health care entities under the premise that the information is based on “trustworthy, non-misleading scientific evidence.” Under the bill, the pharmaceutical/device company and physician must clearly differentiate between FDA-approved uses for the drug or device and off-label information if the therapy is approved for other uses.

Guthrie noted that this bill has been revised since last year based on technical assistance from FDA. A new version was introduced during the markup as a substitute amendment. The updated version of the legislation broadens the scope of the original bill to include devices and adds that the information that is shared must be “truthful and non-misleading.” Republican supporters argued that although physicians are legally allowed to prescribe pharmaceuticals for off-label uses, manufacturers are at risk of prosecution and criminal penalties for discussing and promoting alternative use. 

The bill passed on a party-line vote, with some Democrats raising concerns that the bill could undermine the FDA and put patient health at risk. Full Committee Ranking Member Frank Pallone noted his belief that the legislation could lead to “the coverage of wholly unapproved drugs and would limit FDA’s ability to act against inappropriate actions by manufacturers.” Additionally, Representative Anna Eshoo observed that the bill does not require manufacturers to share health care economic information (HCEI) and scientific information with FDA, even if FDA requests the information.

The Committee rejected two Democratic amendments: one that would prevent communication about a product that had not yet been approved by the FDA and another that would require companies to provide the FDA off-label communication requested by the FDA respectively.

Over-the-Counter Regulation

The bipartisan Over-the-Counter Monograph Safety, Innovation, and Reform Act would overhaul FDA regulation practices for OTC drugs and supply an increase in available resources to the FDA to oversee non-prescription medicines. Successful passage would lead to the first changes to over-the-counter regulation in more than 40 years and would direct the creation of a mechanism for faster safety label changes, establish pathways for innovation, and authorize a new user fee program that could bring in $120 million in funding through 2022. Thirty FDA employees currently devote their time to over-the-counter issues; the increase in funding through this legislation would allow the FDA to hire 100 additional staff.

Under the bill, FDA would be able to update OTC monographs without going through the rule making process, which is so cumbersome that products can remain on the shelves for decades before FDA can require updated labeling or formulation changes.

The legislation passed by voice vote, despite the concerns expressed by some Democrats on the Committee.


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