Life Science Compliance Update

March 09, 2016

Endo New York Settlement Announcement

New York Attorney General Eric T. Schneiderman announced an agreement with Endo Health Solutions, Inc. and Endo Pharmaceuticals, Inc. (collectively, "Endo"), which make and sell Opana ER, a long-acting opioid.

Opana, one of Endo's prescription drugs, was long abused in New York State. In May 2011, for example, after a spike in opioid prescribing and abuse, Nassau County issued a Public Health Alert on the increasing use and abuse of Opana ER, warning both the public and law enforcement of the dangers associated with the prescription drug. In July 2012, USA Today reported that Opana ER was actually the drug of choice for people seeking narcotics, and that in Nassau County, hundreds of people each month were seeking treatment for addiction to Opana ER.

As a result of concerns regarding both Opana ER's role in the larger opioid abuse epidemic and Endo's marketing practices, the Office of the Attorney General opened an investigation into Endo, focusing on Opana ER. The Attorney General found that Endo improperly marketed Opana ER as designed to be crush resistant, when Endo's own studies actually showed that the pill could be crushed and ground up. While this may have bolstered Opana ER sales, it also may have provided a false sense of security to healthcare providers and their patients. The Attorney General also found that Endo improperly instructed its sales representatives to diminish and distort risks associated with Opana ER, including serious dangers involving addiction.

Endo also claimed that Opana ER was distinguishable from its main competitor, OxyContin, because patients who take Opana ER need less rescue medication than those who take OxyContin. This claim, made by sales representatives in sales calls, was not supported by any clinical evidence or study.

The Attorney General's investigation found that Endo had no meaningful program in place to ensure that its sales representatives were not encouraging healthcare providers who are engaged in abuse and diversion to write more prescriptions for Opana ER. This was of particular concern because multiple New York healthcare providers who were heavily "detailed" by Endo were subsequently convicted of illegally prescribing prescription opioids (see p. 10-12 of Settlement).

According to Attorney General Schneiderman, "The public health crisis created by improper opioid prescribing in New York remains pervasive and extremely dangerous. My office is committed to ensuring that prescription drugs are marketed and prescribed responsibly – and that consumers get the information they need about the serious risks associated with painkillers, such as addiction."

The Office of the Attorney General has compelled Endo to change its practices in light of their "deceptive and unlawful conduct."

Endo must implement the following corrective measures:

  • Provide truthful and complete information regarding addiction risks associated with Opana ER;
  • Stop improperly marketing Opana ER as crush resistant;
  • Create an Abuse and Diversion Detection Program that requires Endo's sales representatives to report to the company any healthcare providers they suspect of engaging in abuse and illegal diversion of opioids;
  • Post results of clinical studies on Endo's website; and
  • Provide healthcare providers with information about addiction treatment resources for their patients.
  • Inform NY providers both in writing and orally to participate in the FDA ER-LA REMS Prescriber Education each year

Attorney General Schneiderman also imposed a $200,000 penalty on Endo for its unlawful conduct.

Settlement Specifics

In addition to the aforementioned items, the Settlement went through the findings that Attorney General Schneiderman found, including that in addition to an annual salary, Endo's sales representatives were eligible for a bonus based partly on the number of Opana ER prescriptions written by healthcare providers they were permitted to call upon. Attorney General Schneiderman felt as though such a bonus scheme may create an incentive to encourage more Opana ER prescribing.

The Settlement also mentions that Endo neither admitted nor denied Attorney General Schneiderman's findings in the Settlement and that Endo did cooperate with the Attorney General investigation.

The Settlement also laid out specific plans and requirements for the aforementioned Abuse and Diversion Detection Program, including the filing of a written report with Endo's Legal Department when sales representatives or medical liaisons observe or learn of situations that may suggest that a healthcare provider whom they contact for the purpose of promoting Opioid Medications may be involved in the abuse or diversion of opioids.

This settlement is not the light at the end of the tunnel for Endo. Earlier this month, they said they are still facing other regulatory probes and lawsuits related to its opioid sales and marketing practices.

January 04, 2016

New Hampshire Legislation Targets Boards that Govern Opioid Prescribers

This year the presidential primaries in New Hampshire are bringing to national attention the crisis of Opioid addiction.  In a small state like New Hampshire their rate of 400+ overdose deaths a year, brings the issue to the forefront. At New Hampshire town hall meetings candidates are asked hard questions about issues related to Opioid abuse.

The New Hampshire State House has proposed legislation that would require all state regulatory boards governing opioid prescribers to update their rules in light of the recent New Hampshire opioid epidemic. Such an update would have a wide-ranging effect, from anesthesiologists to veterinarians.

The Board of Medicine is currently working on "emergency rules" to better control the amount of opioids that are being prescribed to patients. However, under the new legislation sponsored by Representative Cindy Rosenwald, other boards covering nurses, dentists, ophthalmologists, and others would have to update their rules to reflect the best practices for prescribing prescription medications, especially opioids.

Senate Majority Leader Jeb Bradley is a co-sponsor of the bill and chair of the Joint Task Force for the Response to the Heroin and Opioid Epidemic in New Hampshire. Mr. Bradley believes these proposed changes will have to be in conjunction with prescribers so they can consider the needs of all patients. Mr. Bradley is planning to continue with this legislation that will place a new burden on many in the medical field, stating that "this will require a lot of give and take negotiations with physicians and everyone else."

Representative Thomas Sherman noted that only the Board of Medicine currently has emergency rules in place and suggested other boards begin to do the same. Sherman, a physician, is concerned that if other regulatory boards do not move forward now, the prescribers that they oversee will be working under the old rules while physicians will be under the new rules.

The Task Force reviewed Senator Bradley's proposal to require prescribers to take an online test on the safe prescribing of opioids and other controlled drugs when they renew their licenses. This would ensure that if a physician failed the test, he or she would have to take a continuing medical education program and then retake the test. Since each specialty and subspecialty is different, each regulatory board would need to work to develop their own test, or Senator Bradley posited, they could work together to create one master test.

Senator Bradley believes that this proposal is a compromise with some lawmakers who would like to mandate continuing medical education programs on opioids, a move many physicians and regulator boards oppose. As Louise Lavertu, executive director of the Joint Board of Licensure and Certification stated, the agencies do not have the technology for online tests. Lavertu commented that "it would have to be put out for bid" and that costs are a concern for such a requirement.

Sarah Blogett, the director of the board's Health Professions, indicated that other states do require continuing medical education programs, not a separate test. As such, Senator Bradley requested that the medical society and the dental society work together with their regulatory boards to attempt to reach an agreement on either a mandatory continuing medical education requirement, or additional testing.

The Task Force has convened to "look at a range of possible solutions to the state's substance abuse crisis, including harsher penalties on the distribution of fentanyl, establishing a statewide drug court program and requiring more involvement in the state's prescription drug monitoring program."

The state's Task Force will continue their work and issue a preliminary report by December 22, 2015, and a final report by January 6, 2016. The Task Force is working to determine which bills have broad agreement and will be able to be fast-tracked to the governor's, Maggie Hassan, desk by mid-January 2016, and which bills will take further discussion and a longer period of time to complete the legislative process.

Gov. Hassan is eager to find a resolution to the state's heroin/opioid epidemic that has claimed over 600 lives in the past two years alone. She called for a special session in November 2015, but the House and Senate were unwilling to act on Gov. Hassan's proposed legislation, creating the Task force instead.

December 15, 2015

Update on Risk Evaluation and Mitigation Strategies

For many years, we have written about the authority granted to the FDA from the 1997 Food and Drug Administration Amendments Act of 2007 which requires REMS (Risk Evaluation and Mitigation Strategy) from drug and biologics manufacturers for products to ensure that any serious risks are outweighed by its benefits. REMS requirements can impose special duties on manufacturers, wholesalers, pharmacists, physicians, and/or patients. Failure to comply with a REMS potentially has significant legal consequences and patient safety implications.

Years ago we saw CME under attack by critics charging the education representing a way around FDA's control of medical promotion. REMS changed this trend as the agency turned back to CME as the keystone to controlling a tough drug overuse/abuse situation. Specifically, FDA's REMS approach for long-acting opioid pain products relies on physician education with materials pre-approved by FDA as the key post-marketing control tool.

Now, many years later, FDA recently launched REMS@FDA, a REMS database website. The user-friendly website contains a table of all currently approved individual and shared REMS, as well as a link to historical REMS. The table provides an at-a-glance overview of elements included in each REMS and links to detailed pages for the REMS. All REMS materials are downloadable in PDF format.

FDA has developed a number of REMS-related priority projects and in an October 2015 Federal Register announcement, the agency introduced a pilot project for the submission of final approved REMS and certain REMS summary information electronically in a standard Structured Product Labeling (SPL) format. The goal is to make it easier for these documents to be integrated into pharmacy and hospital IT systems. 

FDA says that stakeholders have "expressed concern that information about REMS materials, tools, and requirements are not communicated … in a clear and consistent manner," and that "REMS materials and requirements may be difficult to locate," and "difficulty integrating REMS materials and procedures into their existing health information systems and healthcare delivery processes." FDA says it is looking for no more than nine volunteers to take part in the pilot and asks interested parties to apply by December 7, 2015. 

Also recently, twenty health care provider and patient advocacy organizations forces announced an effort to counter what they view as recent efforts to weaken REMS linked to certain FDA-approved drugs. The move comes as generic drug advocates raise concerns that brand-drug makers are using REMS restrictions to delay generic competition. The group, Patients Alliance for Drug Safety Protections, says patients, policy makers and other key stakeholders have an extensive knowledge gap about how REMS work. The goal of the alliance and the website is to educate the public on FDA's use of REMS to approve high-risk medications that would otherwise not be on the market and to keep them from being diverted to the black market. 

Among the priority issues for the Alliance will be to preserve the integrity of safety programs like REMS with Elements to Assure Safe Use (ETASU). Drugs that are covered by REMS with ETASU face the greatest set of restrictions, including the use of registries, education programs for providers, pharmacies and patients, monitoring, and restrictions on distribution. Although these programs can add time and administrative requirements for health professionals and can be expensive for manufacturers to develop and operate, these extensive safety measures are required by the FDA under federal law to ensure that a drug's benefits will outweigh its risks. ETASU components are rare, as only 36 drugs as to date have these programs.

 

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