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The Maine legislature passed with broad bipartisan approval L.D. 911, An Act to Prohibit Certain Gifts to Health Care Practitioners. The legislation prohibits gifts to practitioners who are licensed to prescribe and administer drugs by manufacturers, wholesalers, or agents of manufacturers or wholesalers of prescription drugs.
- Free samples of prescription drugs for patients
- Items less than $50 over a calendar year
- Payments to sponsors of educational programs
- Honoraria for educational conferences
- Compensation for research
- Publications or educational materials
- Salaries to employees
At the Heart of the Bill is the State’s Opioid Crisis
While similar in substance to what already exists in Massachusetts, Vermont, and other states as a law designed to curtail conflicts of interest in physician prescribing practices, the purported impetus here is the state’s opioid crisis. Representative Scott Hamann, the sponsor for the bill, said that the goal is to ensure doctors do not have conflicts of interest when prescribing drugs, especially opioids. According to Hamann’s testimony before the legislature, “People are dying, and the addiction often starts in the doctor’s offices.” The bill intends to curb any influence on the prescribing of opioids given the perspective that there is a correlation between payments and prescribing behavior. Maine has seen a forty percent increase in drug overdose deaths in the last year, and spending on physicians nearly doubled from 2014 to 2015.
The “gift ban” law is now awaiting the Maine Governor’s signature. It will be interesting to see if other states impacted heavily by heroin and opioid abuse will follow suit with increased surveillance or banning of industry gifts to physicians.
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Fresh off his noticeably smooth confirmation, the new Commissioner of Food and Drugs, Dr. Scott Gottlieb, appeared before Congress last Thursday and unveiled his strategic initiatives and priorities for the Trump Food and Drug Administration (“FDA”). These run the gamut from improving regulatory science and policies to streamlining clinical trials to spurring innovation on behalf of patients. Two initiatives, in particular, merit closer attention and discussion: combating opioid abuse and addressing drug price increases through more, accelerated generic competition.
In his first post to the FDA Voice blog, Dr. Gottlieb wrote:
As Commissioner, my highest initial priority is to take immediate steps to reduce the scope of the epidemic of opioid addiction. . . . I believe it is within the scope of FDA’s regulatory tools – and our societal obligations – to take whatever steps we can, under our existing legal authorities, to ensure that exposure to opioids is occurring under only appropriate clinical circumstances, and for appropriate patients.
First among these steps, the Commissioner is establishing an Opioid Policy Steering Committee, comprised of “some of the agency’s most senior career leaders, to explore and develop additional tools or strategies FDA can use to confront this epidemic.” The strategies under consideration include (1) mandatory education for health care professionals about (i) appropriate prescribing recommendations; (ii) how to identify the risk of abuse in individual patients; and (iii) how to get addicted patients into treatment; and (2) working more closely with provider groups to develop standards for prescribing opioids in different clinical settings, so that “the number of opioid doses that an individual patient can be prescribed is more closely tailored to the medical indication.”
Limiting the availability of prescription pain medication is a dicey proposition, however. As Dr. Gottlieb acknowledged, certain situations “require a 30-day supply” and, “[i]n those cases, we want to make sure patients have what they need. But there are plenty of situations where the best prescription is a two- or three-day course of treatment.” The individualized medical judgments and circumstances that drive opioid prescribing likely mean that no single approach is likely to strike the proper balance between over-prescribing and ensuring sufficient access to adequate pain management. Interestingly, the variability between opioid prescribers and patients did not stop the Centers for Medicare and Medicaid Services from proposing hard limits on opioid dosing for non-cancer pain or palliative/end-of-life care (i.e., chronic pain) for Medicare Advantage Organizations and Prescription Drug Plan Sponsors.
In fact, pain patients already have struggled under bright-line limitations on opioids. As we previously reported, the State of Massachusetts enacted a new law in March 2016 that prohibits “a practitioner [from] issu[ing] a prescription for more than a 7-day supply . . . [w]hen issuing a prescription for an opiate to an adult patient for outpatient use for the first time [or] to a minor,” the first such limitation legislatively imposed by any state.” Mass. Gen. Laws ch. 94C, § 19D (2016). Massachusetts physicians surveyed following the law’s enactment complained that “the pendulum has swung too far, depriving pain patients of needed relief,” and that “regulations won’t solve the addiction problem . . . . Instead, they make doctors reluctant to prescribe opioids.”
Broadly targeting opioids as a class of drugs also may cast too wide a net. A recent article in the journal Substance Abuse reported “[t]he US opioid epidemic has changed profoundly in the last 3 years” in that “[h]eroin and fentanyl have come to dominate an escalating epidemic of lethal opioid overdose, whereas opioids commonly obtained by prescription play a minor role, accounting for no more than 15% of reported deaths in 2015.” The article urged that the changing etiology of opioid overdose “require[s] substantial recalibration of the US policy response.”
What is clear—and what Dr. Gottlieb seems to recognize—is that opioid abuse and addiction are dynamic issues that differ from prescriber to prescriber and from one patient to another. Those variables may make a one-size-fits-all strategy unviable.
During a budget hearing before the House Committee on Appropriations, Dr. Gottlieb testified that, “while the FDA does not have a direct role in drug pricing, we can take steps to facilitate entry of lower-cost alternatives to the market.” He identified policy challenges that the last Congress had attempted to address through legislation designed to expedite access to affordable drugs. Such legislation included the CREATES Act, which we previously analyzed. The proposed law sought to prevent brand-name drug companies from using FDA safety rules (i.e., Risk Evaluation and Mitigation Strategies (REMS) and requirements thereunder, e.g., Elements to Assure Safe Use (ETASU)) for medicines with higher risk potential to block or delay generic entry. “FDA has an important role to play in making sure that its statutory and regulatory processes are working as intended,” Gottlieb told Congress, “not being manipulated in ways that FDA and Congress did not intend.”
In response to growing political pressure in Washington to expedite drug reviews, Dr. Gottlieb assured lawmakers that biomarkers, new technologies, and more efficient clinical trial designs would make it possible to shorten the regulatory process. But accelerated approval of expensive, investigational (albeit life-saving) therapies has raised concerns among health policy experts.
A recent op-ed published by the New England Journal of Medicine (NEJM) cautioned that
accelerated approval can lead to situations in which private payers may choose not to cover a drug because of high cost and lack of evidence of clinical efficacy, thereby thwarting the pathway’s goal of getting potentially important therapies to patients earlier, while major government payers are forced to cover the product, directing substantial tax dollars to drugs not yet shown to have clinical benefit.
The NEJM article’s authors argue that any biopharma company granted an accelerated approval should be subject to certain price restrictions until the confirmatory trials are completed, reasoning that “the price paid by taxpayers should reflect the strength of the available evidence about the drug’s clinical impact.” Additionally, they proposed that all drugs moving through an accelerated-approval pathway should be subject to formal economic impact analyses after one to two years on the market, possibly funded by an increase in the user fees for manufacturers that use this pathway.
Dr. Gottlieb is also evaluating the generic drug and biosimilar review and approval process. More specifically, Dr. Gottlieb is looking at measures to facilitate communication between the industry and FDA, address complex molecules, and to speed up the approval of biosimilar products.
These recommendations are not without some appeal. Despite seeking to deliver more “bang” for the taxpayer’s “buck,” however, prospectively capping the federal reimbursement for a high-cost drug product still subject to additional clinical trials and/or other R&D may create a financial disincentive to pharmaceutical manufacturers to foot the expense of developing breakthrough drugs to fill an unmet medical need.
To deliver on the promises of reducing the incidence of opioid abuse and lowering drug prices, Dr. Gottlieb’s FDA must navigate the competing interests and thorny health policy issues highlighted above. Foley & Lardner will report further as the agency’s redefined mission unfolds.
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New Hampshire is starting 2017 with stepped-up efforts to manage its oft-described opioid epidemic. Though the most recent regulations are directed at individual prescribers, and do not apply to the administration of opioids to patients in a health care setting, now is the time for New Hampshire hospitals, ambulatory surgical centers, urgent care facilities, and other health care facilities to revisit their protocols, record-keeping practices, and informed consent agreements relating to opioid prescribing.
In recent weeks the New Hampshire Board of Medicine and the Board of Nursing have each finalized and adopted, with minor amendments, emergency opioid prescribing rules that had been issued during 2016. Both sets of rules were effective January 1, 2017.
The final regulations follow on the heels of clinical guidelines and standards for managing chronic, non-cancer pain with opioids that have been published by the Centers for Disease Control and Prevention and various national professional societies, by establishing a legal framework of safe opioid prescribing practices for New Hampshire physicians and advanced practice registered nurses (APRNs). The regulations also provide 3 exemptions from the general requirement to query the Controlled Drug Prescription Health and Safety Program (the State’s prescription drug monitoring program or “PDMP”).
The final regulations set forth a laundry list of requirements that New Hampshire APRNs and physicians must meet before they may prescribe (or continue to prescribe) opioids to treat non-cancer and non-terminal pain (acute and chronic). Specifically, licensees must, among other things and with certain limited exceptions, query the PDMP, conduct and document a history and physical exam, conduct and document a risk assessment (the evidence-based screening tool Screener and Opioid Assessment for Patients with Pain (SOAPP) is suggested but not required), prescribe the lowest effective dose for a limited duration, document a pain treatment plan, create and document a written treatment agreement with the patient, and utilize a written informed consent that explains risks associated with opioids, including addiction, overdose and death, physical dependence, physical side effects, hyperalgesia, tolerance, and crime victimization. The rules also specify the information that must be provided to patients prior to prescribing opioids for either acute or chronic pain. In an emergency department, urgent care setting, or walk-in clinic, opioid prescriptions cannot exceed 7 days (or such fewer days as may be medically necessary to treat the patient’s medical condition). Clinical coverage must be made available 24 hours per day, 7 days per week for the management of patients treated with opioids for chronic pain.
The goal of these final regulations is to encourage licensees to assure that opioids are prescribed to New Hampshire patients only in limited and clinically appropriate circumstances, and that sufficient information, tools, and support are made available to patients to prevent overuse, addiction, and overdose. Practitioners who historically have been adverse or resistant to treating pain with opioids due to the potential for patient overuse or addiction, or concerns for personal liability, can now rely upon the rules as a legal framework and best practice for safe prescribing practices. The adoption of these final rules should serve as a reminder to New Hampshire health care facilities that all of its prescribing practitioners play a vital role in combatting opioid abuse in New Hampshire, which has been characterized by federal Drug Enforcement Agency officials as “ground zero” in the opioid epidemic.
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