Life Science Compliance Update

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32 posts from January 2017

January 31, 2017

Mallinckrodt to Pay $100M to Settle Antitrust Violations

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Mallinckrodt ARD Inc., formerly known as Questcor Pharmaceuticals, Inc., and its parent company, Mallinckrodt plc, have agreed to pay $100 million to settle Federal Trade Commission (FTC) charges that they violated antitrust laws when Questcor acquired the rights to a drug that threatened its monopoly in the United States market for adrenocorticotropic hormone (ACTH) drugs. The drug, Acthar, is used as a treatment for infantile spasms, as well as a drug of last resort for other serious medical conditions. A treatment with Acthar can cost more than $100,000.00.

The complaint alleges that, while benefitting from an existing monopoly over the only U.S. ACTH drug, Acthar, Questcor illegally acquired the U.S. rights to develop a competing drug, Synacthen Depot. The acquisition stifled competition by preventing any other company from using the Synacthen assets to develop a synthetic ACTH drug, preserving Questcor’s monopoly and allowing it to maintain extremely high prices for Acthar.

The FTC alleges that in June 2013, Questcor acquired the U.S. rights to Synacthen from Novartis AG, outbidding several other companies that were seeking to acquire the rights to Synacthen. Those alternative bidders were interested in developing the drug and had plans to sell it at a significant discount to Acthar’s price, capturing a substantial amount of Questcor’s business. The FTC charges that Questcor’s acquisition of Synacthen stifled competition and eliminated the possibility that an alternative bidder would make the drug available in the U.S. market and compete with Acthar.

“Questcor took advantage of its monopoly to repeatedly raise the price of Acthar, from $40 per vial in 2001 to more than $34,000 per vial today – an 85,000 percent increase,” said FTC Chairwoman Edith Ramirez. “We charge that, to maintain its monopoly pricing, it acquired the rights to its greatest competitive threat, a synthetic version of Acthar, to forestall future competition. This is precisely the kind of conduct the antitrust laws prohibit.”

In addition to the $100 million monetary payment, the proposed stipulated court order requires that Questcor grant a license to develop Synacthen Depot to treat infantile spasms and nephrotic syndrome to a licensee approved by the Commission.

A monitor will ensure that Questcor complies with its obligation to grant the license within 120 days of the entry of the order; after that time, a trustee will be appointed to effectuate the license. The order also requires Questcor to provide periodic reports on its efforts, and provide the Commission with advance notice of any future acquisitions of U.S. rights to ACTH drugs.

Shkreli Resurfaces…

The FTC has been investigating Mallinckrodt's Questcor unit since a 2014 lawsuit filed by notorious ex-pharmaceutical executive Martin Shkreli, then CEO of drug maker Retrophin.

Retrophin's suit claimed Questcor violated federal antitrust laws by purchasing Synacthen from Novartis for $135 million after Retrophin bid $16 million for the drug. Retrophin claimed Questcor's purchase was illegal because it was allegedly done to shut down a drug that could compete with Achthar.

Retrophin settled its case against Questcor in 2015 after Questcor paid Retrophin $15.5 million.

Conclusion

The states of Alaska, Maryland, New York, Texas, and Washington joined in the FTC’s complaint. Under the settlement, the states will receive $10 million from the $100 million judgment and an additional $2 million as payment for attorney’s fees and costs.

In a statement issued Wednesday, Mallinckrodt said, "We are pleased to confirm that we have entered into a settlement agreement with the FTC staff to fully resolve this matter, subject to approval by the commission. We will comment further at the appropriate time."

January 30, 2017

Senate Finance Committee Holds Hearing on Dr. Price to Lead Department of Health and Human Services

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On Tuesday, January 24, 2017, the Senate Committee on Finance held a hearing to consider the nomination of Representative Thomas Price, M.D., to be Secretary of the Department of Health and Human Services (HHS). The hearing was the last for Dr. Price before the entire Committee holds its formal vote on confirmation and provided key insights to Representative Price’s views on healthcare reform, from the Affordable Care Act (ACA) repeal and replace to Medicare and Medicaid reform.

The hearing somewhat highlighted the division between the political parties, with Democrats focusing on concerns surrounding Representative Price’s healthcare investments, his previous statements on health policy, and his legislative record combating the ACA. On the other hand, Republican support for Representative Price remained strong, and he seems to be on track for confirmation some time over the next couple of weeks.

Opening Remarks

In his opening remarks, Senate Finance Committee Chairman Orrin Hatch offered glowing remarks on Representative Price’s qualifications to lead HHS, noting that he has the “experience and qualifications necessary to effectively lead this large and diverse set of agencies.” Chairman Hatch noted numerous stakeholder organizations that have “enthusiastically” supported Price’s nomination, including the American Medical Association, the American Hospital Association, and the Healthcare Leadership Council.

Senator Hatch also criticized Senate Democrats for their “grossly exaggerated attacks” on Representative Price’s record, attempting to derail his nomination. “I have never seen a party in the Senate – from its leaders on down – publicly commit to not only opposing virtually every nomination, but to attacking and maligning virtually every single nominee,” noted Chairman Hatch.

Senate Finance Committee Ranking Member Ron Wyden voiced concerns surrounding Representative Price’s nomination for HHS Secretary. Senator Wyden pointed to the Trump Administration’s promises not to cut Medicare and Medicaid, noting that the President’s positions are in contrast with Representative Price’s policy positions.

Senator Wyden labeled Representative Price’s ACA replacement plan as “repeal and run,” stating that if it became law, “18 million Americans would lose their health care plans in less than two years.” Senator Wyden expressed concern the future of women’s health and coverage for individuals with pre-existing conditions if Representative Price’s replacement bill were enacted.

In his opening remarks, Representative Price spoke fondly about his time as a physician and legislator in the Georgia State Assembly, highlighting his experience in strengthening children’s healthcare throughout his tenure. Representative Price also complimented HHS’ “incredible work” in the areas of drug treatment research, as well as food safety. Representative Price commented on his frustrations with the current healthcare system, noting that the system has lost focus on its top priority: the patient. He emphasized a “bipartisan, team-driven” policy when it comes to reforming healthcare, calling for a “patient first” system that strengthens medical innovation, accessibility, and choice.

Discussion and Commentary

Affordable Care Act

Senate Democrats harped on several different issues related to repeal and replace of the ACA, especially focused on the ACA’s individual mandate and the ban on denying coverage based on pre-existing conditions. Representative Price strongly stated that Republicans will not “abandon” people with pre-existing conditions as the Republican-led Congress makes plans to repeal and replace the law. Additionally, Representative Price voiced support for extending funding for the Children’s Health Insurance Program (CHIP).

Representative Price noted that he would not commit to utilizing the executive order issued by President Trump to eliminate the ACA individual mandate, nor did he promise that no one would lose coverage because of the executive order. “I’m humble enough to appreciate and understand that I don’t have all the answers,” Representative Price said, stating that “the people in the department have incredible knowledge and expertise.” Additionally, Representative Price did not comment on whether HHS would wait for Congress to prepare a replacement plan before taking steps to dismantle the ACA, noting that he would promise to put “patients at the center of healthcare.”

Sunshine Act

During the hearing, Senator Chuck Grassley went into detail about the Sunshine Act that he worked hard to implement. Senator Grassley noted that several years back, he worked hard to get the Patient Physician Sunshine Act passed in Congress, and that it took the prior Administration several years to get the Act in full swing, working the way it was intended. Senator Grassley questioned Dr. Price as to whether he would help support an expansion of the Sunshine Act, to include nurse practitioners and others, because he feels that the increased transparency is truly a good thing for patients and the healthcare industry as a whole.

When Dr. Price responded, he did not give a yes or no answer, instead opting to note that he does believe transparency is vital in so many different ways in health care, including drug pricing and industry interactions, so that patients can understand what is going on in the health care system.

Medicare and Medicaid Reform

Throughout Representative Price’s confirmation process, Democrats have emphasized that his position on Medicare and Medicaid is at odds with President Trump’s promise not to cut either program.  In the Senate hearing, Representative Price stated that Medicare must be reformed if the government wishes to keep its promise to seniors, while avoiding questions surrounding his support of reforming Medicaid into a block grant program, only commenting that he is in favor of turning Medicaid into a system “that responds to patients, not government.”

Representative Price indicated some support for the Center for Medicare and Medicaid Innovation (CMMI), calling it “vehicle that might help” incentivize innovation. At the same time, however, he also argued that the directives and programs from CMMI should not be mandatory, and that the center’s work had “gotten a bit off track” during the previous Administration.

Education at ACC Chapter Meetings Positively Impacts Management of Severe or Resistant Hypercholesterolemia: Preliminary Results

Medical-education

Despite guideline-directed statin therapy, the majority of patients with severe hypercholesterolemia and other high-risk populations continue to have a substantial residual risk of cardiovascular disease (CVD). In patients with severe or resistant hypercholesterolemia, new and emerging treatments to reduce low-density lipoprotein cholesterol (LDL-C) offer additional options to control CVD risk.

To address the gap in care of patients with severe or resistant hypercholesterolemia and enhance awareness about emerging agents, an educational series comprised of five 1-hour lectures was developed by a steering committee of two expert faculty. The content was developed to provide guideline-driven information and clinical trial data on reducing LDL-C levels in patients with severe or resistant hypercholesterolemia who are at high risk for CVD. The activities were held in conjunction with regional chapter meetings of the American College of Cardiology (ACC).

To date, three lectures have taken place, with a total of 186 participants attending. Nearly three-quarters of attendees were MDs/DOs, 62% of whom specialized in cardiology. The majority of participants (60%) reported seeing more than 60 patients with hypercholesterolemia each month. The activity content was found to be highly relevant to the participating clinicians, with 99% agreeing it prepared them to better care for patients and gave them tools/knowledge to change practices to improve care. Interestingly, even in this highly-experienced group of cardiologists, as many as 69% of participants indicated that at least half of the content was new to them.

Preliminary outcome findings demonstrate that participation increased attendee confidence regarding their management of patients with severe/resistant hypercholesterolemia who are at risk for major adverse cardiovascular events. At baseline, 60% of participants felt “confident,” “very confident,” or “expert,” which rose to 90% post activity. After the activity, 78% of participants reported that they will increase monitoring of patient LDL-C levels to assess compliance and response to therapy after participating in this activity, indicating that the education has the potential to positively impact the care of patients with severe or resistant hypercholesterolemia who are at risk of CVD.

Early results also suggested improved knowledge regarding the degree of reduction in the risk of major adverse CVD events with LDL-C reduction to 50 mg/dL (pre-test, 25%; post-test, 73%; P<0.005); the impact of statins on CVD risk (pre-test, 23%; post-test, 56%; P<0.005); and the beneficial impact of LDL-C reduction on the rates of adverse clinical events (pre-test, 42%; post-test, 71%; P<0.005). Improved post-test knowledge was also observed regarding agents for lipid reduction, including CTEP inhibitors, which are still in development (pre-test, 20%; post-test, 80%; P<0.005); identifying the drug class for PCSK9 inhibitors (pre-test, 77%; post-test, 97%; P<0.005); and the indication of a microsomal triglyceride transfer protein inhibitor and an oligonucleotide inhibitor of apo B-100 synthesis (pre-test, 48%; post-test, 90%; P<0.005).

Based on the calculation of the effect size, it is estimated that the cardiologists who attended the activity are 55.4% more likely to deliver evidence-based care to the 83,000 patients seen each year with severe/resistant hypercholesterolemia who are at risk for major adverse cardiovascular events.

In conclusion, while additional data are needed, these preliminary observations support the concept that this regional lecture series has a positive impact on cardiologists’ knowledge, confidence, and practice in managing patients with severe or resistant hypercholesterolemia. In addition to collecting more data from participants at the remaining two venues, we will collect insights into their practice changes during a follow-up survey sent approximately 6 weeks after each live activity.

The initiative, “Managing Severe or Resistant Hypercholesterolemia: The Next Generation of LDL-C Lowering Agents,” is jointly provided by the Potomac Center for Medical Education and Rockpointe and supported by an educational grant from Amgen. The Potomac Center for Medical Education is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.

Authors

Carole Drexel, PhD, CHCP, Rockpointe Corporation and Potomac Center for Medical Education, Columbia, MD

Kathy Merlo, CHCP, Rockpointe Corporation and Potomac Center for Medical Education, Columbia, MD

Leanne Berger, Rockpointe Corporation and Potomac Center for Medical Education, Columbia, MD

Thomas Sullivan, Rockpointe Corporation and Potomac Center for Medical Education, Columbia, MD

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