Life Science Compliance Update

April 18, 2018

Gottlieb Discusses Opioids and Lays Out Vision

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On Wednesday, April 4, 2018, Food and Drug Administration (FDA) Commissioner Scott Gottlieb spoke at the National Rx Drug Abuse and Heroin Summit. Gottlieb opened by comparing recent opioid deaths to those that happened at the peak of the AIDS epidemic in 1995. He started off discussing different strategies the FDA has pursued to address the challenges presented by the current crisis, especially those that help reduce overall exposure to opioids and preserve access for the patients who need them.

He mentioned that often, the opioid addiction “starts with a prescriber’s pen, either directly or indirectly,” meaning either they are prescribed the drugs directly or they receive leftover, stolen, or otherwise acquired drugs, of family and friends. He noted there is a lack of evidence-based guidelines to inform clinical practice for opioid use, and this is hampering prescribers from providing personalized pain management and addiction treatment at the point of care.

Throughout his speech, Gottlieb highlighted four main areas for improvement to address the opioid epidemic: supporting education and training, developing evidenced based guidelines, enhancing enforcement, and advancing electronic prescribing systems and policies.

Supporting Education and Training

Commissioner Gottlieb did acknowledge the revised FDA Blueprint and the way its regulatory authority was extended, but also stated that FDA’s REMS is optional for prescribers. He went so far as to suggest that it may be time to consider making it mandatory, “given the scale of the epidemic.” One potential approach that he suggested would be to require the training of the prescribers at the time they register with the DEA and again at registration renewal.

Commissioner Gottlieb continued, noting, “This training could also include information about the appropriate dose and duration of opioid analgesic use for the most common outpatient indications. To reinforce this training, this information could be made easily available at the point of care so practitioners could incorporate more of it into their prescribing decisions.”

Evidence-Based Prescribing

He also expressed a desire to collaborate with professional societies to develop evidence-based guidelines on the appropriate dose and duration for some common procedures. He suggested that this new data and evidence would not be relied upon for primary evidence of effectiveness, but instead, on how providers can better use the drugs when there are significant safety concerns present about abuse.

He also stated, that the Agency and the public need to seek better information that we could more easily incorporate into the labels of opioid alternatives; like when an NSAID and acetaminophen combination is a suitable, if not better alternative to an immediate release opioid. He also mentioned a proposal the FDA is pursuing to streamline the monograph process that currently governs Over-the counter (OTC) labeling could allow this kind of information to be more easily incorporated into the labels of common OTC pain relievers.

E-Prescribing

Gottlieb offered support for improving prescribing platforms that make it easier for doctors to adopt evidence-based guidelines. He believes a “robust e-prescribing system could streamline access for patients with chronic pain who are appropriately managed on an opioid therapy as the history of safe-use could be documented in the system, allowing greater ease for both patients and their providers,” which would allow clinicians and pharmacists to focus their attention on new opioid prescriptions instead of appropriately-managed patients who suffer from chronic pain. 

Commissioner Gottlieb further mentioned his support for Congress’ efforts to pass legislation that would create a uniform system of electronic prescriptions for controlled substances and integration of Electronic Health Records (HER) and Prescription Drug Monitoring Program (PDMP), as well as data sharing across PDMPs.

Enforcement

Gottlieb also called on social media companies, internet service providers and others to collaborate with the FDA to stop illegal efforts to distribute opioids in their tracks. According to Gottlieb, FDA will host a summit meeting with CEOs and other senior representatives of the internet stakeholders, academics, and advocacy groups to identify technology gaps and new solutions.

He referenced a report by the U.S. Senate Permanent Subcommittee on Investigations, which found that online sellers offered to sell fentanyl and ship any purchases through the “international arm of the U.S. Postal Service,” and accepted a variety of payment options, including Bitcoin. The sellers would even offer “flash sales” on their products to entice buyers. The investigators used payment information to identify more than 500 financial transactions totaling $230,000 linked to 300 individuals in 43 states. 

In a hearing on January 25, Senator Rob Portman, the Subcommittee Chair, said that their investigation found that: “…online sellers were quick to respond, unafraid of getting caught, and ready to make a deal. They offered discounts for bulk purchases and even tried to up-sell us to carfentanil – a powerful synthetic opioid that is so strong it’s used as an elephant tranquilizer. Ordering these drugs was as easy as buying any other product online.”   

FDA has investigators conducting some dark web operations, resulting in some notable take-downs. He is asking for the help of internet firms to help the FDA continue to crack down on these violations.

Conclusion

Commissioner Gottlieb ended his speech by recognizing that “we haven’t seen meaningful, voluntary actions,” when it comes to opioids and to that end, the FDA is planning to host a summit with CEOs and other senior representatives of internet stakeholders, academics, and various advocacy groups to identify technology gaps and possible solutions.

Both the House and the Senate are working on a variety of bipartisan proposals that could be included in the next legislative package addressing the opioid epidemic. The House Energy and Commerce Committee has the third in its hearing series on this topic scheduled for April 11th, during which the Committee will consider more than two dozen bipartisan bills. The Senate Finance committee and the Senate HELP committee are both involved in finding a resolution as well and are still working on solidifying hearing dates.

April 06, 2018

Gottlieb Discusses Opioids and Lays Out Vision - Google it's Your Turn

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On Wednesday, April 4, 2018, Food and Drug Administration (FDA) Commissioner Scott Gottlieb spoke at the National Rx Drug Abuse and Heroin Summit. Gottlieb opened by comparing recent opioid deaths to those that happened at the peak of the AIDS epidemic in 1995. He started off discussing different strategies the FDA has pursued to address the challenges presented by the current crisis, especially those that help reduce overall exposure to opioids and preserve access for the patients who need them.

He mentioned that often, the opioid addiction “starts with a prescriber’s pen, either directly or indirectly,” meaning either they are prescribed the drugs directly or they receive leftover, stolen, or otherwise acquired drugs, of family and friends. He noted there is a lack of evidence-based guidelines to inform clinical practice for opioid use, and this is hampering prescribers from providing personalized pain management and addiction treatment at the point of care.

Throughout his speech, Gottlieb highlighted four main areas for improvement to address the opioid epidemic: supporting education and training, developing evidenced based guidelines, enhancing enforcement, and advancing electronic prescribing systems and policies.

Supporting Education and Training

Commissioner Gottlieb did acknowledge the revised FDA Blueprint and the way its regulatory authority was extended, but also stated that FDA’s REMS is optional for prescribers. He went so far as to suggest that it may be time to consider making it mandatory, “given the scale of the epidemic.” One potential approach that he suggested would be to require the training of the prescribers at the time they register with the DEA and again at registration renewal.

Commissioner Gottlieb continued, noting, “This training could also include information about the appropriate dose and duration of opioid analgesic use for the most common outpatient indications. To reinforce this training, this information could be made easily available at the point of care so practitioners could incorporate more of it into their prescribing decisions.”

Evidence-Based Prescribing

He also expressed a desire to collaborate with professional societies to develop evidence-based guidelines on the appropriate dose and duration for some common procedures. He suggested that this new data and evidence would not be relied upon for primary evidence of effectiveness, but instead, on how providers can better use the drugs when there are significant safety concerns present about abuse.

He also stated, that the Agency and the public need to seek better information that we could more easily incorporate into the labels of opioid alternatives; like when an NSAID and acetaminophen combination is a suitable, if not better alternative to an immediate release opioid. He also mentioned a proposal the FDA is pursuing to streamline the monograph process that currently governs Over-the counter (OTC) labeling could allow this kind of information to be more easily incorporated into the labels of common OTC pain relievers.

E-Prescribing

Gottlieb offered support for improving prescribing platforms that make it easier for doctors to adopt evidence-based guidelines. He believes a “robust e-prescribing system could streamline access for patients with chronic pain who are appropriately managed on an opioid therapy as the history of safe-use could be documented in the system, allowing greater ease for both patients and their providers,” which would allow clinicians and pharmacists to focus their attention on new opioid prescriptions instead of appropriately-managed patients who suffer from chronic pain. 

Commissioner Gottlieb further mentioned his support for Congress’ efforts to pass legislation that would create a uniform system of electronic prescriptions for controlled substances and integration of Electronic Health Records (HER) and Prescription Drug Monitoring Program (PDMP), as well as data sharing across PDMPs.

Enforcement

Gottlieb also called on social media companies, internet service providers and others to collaborate with the FDA to stop illegal efforts to distribute opioids in their tracks. According to Gottlieb, FDA will host a summit meeting with CEOs and other senior representatives of the internet stakeholders, academics, and advocacy groups to identify technology gaps and new solutions.

He referenced a report by the U.S. Senate Permanent Subcommittee on Investigations, which found that online sellers offered to sell fentanyl and ship any purchases through the “international arm of the U.S. Postal Service,” and accepted a variety of payment options, including Bitcoin. The sellers would even offer “flash sales” on their products to entice buyers. The investigators used payment information to identify more than 500 financial transactions totaling $230,000 linked to 300 individuals in 43 states. 

In a hearing on January 25, Senator Rob Portman, the Subcommittee Chair, said that their investigation found that: “…online sellers were quick to respond, unafraid of getting caught, and ready to make a deal. They offered discounts for bulk purchases and even tried to up-sell us to carfentanil – a powerful synthetic opioid that is so strong it’s used as an elephant tranquilizer. Ordering these drugs was as easy as buying any other product online.”   

FDA has investigators conducting some dark web operations, resulting in some notable take-downs. He is asking for the help of internet firms to help the FDA continue to crack down on these violations.

Conclusion

Commissioner Gottlieb ended his speech by recognizing that “we haven’t seen meaningful, voluntary actions,” when it comes to opioids and to that end, the FDA is planning to host a summit with CEOs and other senior representatives of internet stakeholders, academics, and various advocacy groups to identify technology gaps and possible solutions.

Both the House and the Senate are working on a variety of bipartisan proposals that could be included in the next legislative package addressing the opioid epidemic. The House Energy and Commerce Committee has the third in its hearing series on this topic scheduled for April 11th, during which the Committee will consider more than two dozen bipartisan bills. The Senate Finance committee and the Senate HELP committee are both involved in finding a resolution as well and are still working on solidifying hearing dates.

April 05, 2018

House of Representatives Holds Two-Day Hearing on Opioids

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Recently the Committee on Energy and Commerce Subcommittee on Health held a hearing entitled, “Combating the Opioid Crisis: Prevention and Public Health Solutions.” During the hearing, representatives and witnesses alike discussed a total of twenty-five bills that have been introduced or drafted and address the opioid crisis.

The Subcommittee on Health heard from four different panels of witnesses, including federal agency heads, recovering addicts, and opioid rehabilitation medical experts.

Opening Statements

During opening statements, Committee Chairman Greg Walden praised the President’s plans to address the opioid crisis and said that Congress is “ready to work in tandem” with the administration to come up with additional solutions. Referencing the importance of the hearing, Rep. Walden said that the proposed legislation would help strengthen the FDA’s ability to understand the epidemic. Rep. Walden specifically referenced The INFO Act (H.R. 4284), and H.R. 3545, as effective bills to help combat the opioid crisis.

Committee Ranking Member Rep. Frank Pallone discussed his support for the Addiction Treatment Access Improvement Act of 2017 (H.R. 3692) which revises the qualifications for physicians to “administer, dispense, or prescribe narcotic drugs for maintenance or detoxification treatment.”

Health Subcommittee Chairman Michael Burgess stated that legislation like the Comprehensive Addiction and Recovery Act (CARA) and 21st Century Cures Act have been impactful, but additional legislation is needed. He expressed concern with how little of the 21st Century Cures Act funding has been used by the states to date. He also highlighted H.R. 4284 and the FDA packaging and disposal discussion draft as two important pieces of legislation.

Subcommittee Ranking Member Gene Green spoke to the FDA Misuse/Abuse discussion draft legislation he authored which would clarify the FDA’s authority to consider tendencies for misuse and abuse as part of the drug approval and assessment process for opioids. He also noted the importance for expanding healthcare access to patients.

Testimony and Discussion

With the four panels and two days of hearings, the Committee had wide-ranging discussions on the bills, sometimes vigorously debating and other times listening intently to the witnesses before them.

Members of the Committee debated the merits of the Overdose Prevention and Patient Safety Act (H.R. 3545), which would address concerns with existing rules governing the privacy of patient medical records related to substance abuse treatment. Democrats claimed the bill would increase instances of discrimination against patients with substance use disorders (SUDs) while Republicans argued it would encourage coordinated and exemplary care for patients seeking treatment.  

More specifically, Representative Walden acknowledged that while this issue is “deeply sensitive” it is important to ensure that patients receiving these services get the same quality of treatment that patients with other chronic diseases get by protecting patient privacy and reducing stigma towards those with SUDs. Representative Pallone on the other hand, stated his belief that the legislation could potentially act as a barrier to patients seeking and receiving treatment. He further stated that Congress should instead focus efforts on eliminating stigma around drug use and pass laws to protect patients with a history of opioid abuse from discrimination.

The Advancing Cutting Edge (ACE) Research Act (H.R. 5002), authored by Debbie Dingell and Fred Upton, would provide authority to fast track research on new non- addictive pain treatments. FDA Commissioner Scott Gottlieb said that the FDA is currently gathering data on pain medication with abuse-deterrent capabilities that will soon be released to the public. Mr. Gottlieb also told the Committee that the FDA currently has the legal authority to address the side effects of illicit drug use but having the authority to explore and expand risk assessment capabilities to drugs outside of the controlled substance category would be helpful to the public. Such authority is proposed in the discussion draft of the FDA Accelerated Approval and Breakthrough Therapy Status Act.

Members agreed on a variety of legislative topics, including proper disposal of unused opioids and an increase in the Food and Drug Administration’s (FDA) authority to seize and destroy packages carrying suspicious and unlabeled pills in international mail facilities (IMFs). Questions did arise, however, regarding legislation that would allow the FDA to consider the risks of misuse and abuse when approving a new drug and to apply the authority for the agency to expedite the approval process for pain and addiction treatments.

Conclusion

This hearing was one of several opioid-related hearings and developments that have occurred recently and Congress currently seems to be working in a bipartisan manner to develop thoughtful legislative packages should they opt to take up new opioid-related legislation in advance of the 2018 midterm elections.

The Subcommittee is preparing for a third hearing about the opioid crisis in April, which will cover Medicare, Medicaid and payer issues and plans. Committee Chairman Walden has said he wants the Committee to complete consideration of bills to address the opioid crisis by Memorial Day. On the Senate side, the Health, Education, Labor and Pensions (HELP) Committee is continuing to review several proposals before finalizing plans to convene a hearing sometime this spring.

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