Life Science Compliance Update

November 23, 2016

Emanuel Announces Efforts to Combat Opioid Abuse Including Registering Pharmacetical Sales Reps

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In early October, Chicago mayor Rahm Emanuel announced a “series of efforts to combat heroin and opioid addiction throughout Chicago.” According to a press release on the City of Chicago’s website, “these proposed efforts would increase the City’s annual investment in addiction treatment by 50 percent…and create improved regulation of pharmaceutical representatives.”

Chicago seems to place much of the blame on pharmaceutical representatives marketing to medical professionals. As such, Mayor Emanuel proposes to “establish a pharmaceutical representative license above the current Limited Business Licensing required for these individuals in Chicago.”

Chicago seems to be following in the footsteps of Washington, DC, noting that “pharmaceutical representatives will be required to receive additional training and education and provide the city with information on opioid sales and marketing.” Through this extra licensing, the city would enable medical professionals to report complaints against pharmaceutical representatives for deceptive and/or unethical behavior and monitor, audit, and adjudicate such complaints. Part of the additional training would focus on prescription abuse, ethics, and marketing practices from programs certified by the city.

Sometime this month, the city expects to introduce an ordinance that would require the extra licensing. The city is also considering requiring pharmaceutical representatives to track which doctors they contact, and potentially supply names to the city upon request. The ordinance would also require licensed representatives to record the number of health providers they contact and the drug information they offer, keep track of when and to whom they hand out samples, and note whether the physicians are compensated for their time.

According to Dr. Julie Morita, commissioner of Chicago’s Department of Public Health, the city is working on how it would enforce the ordinance and punish violators, though pulling a representative’s license might be one such possibility.

The licenses would cost roughly $750 per representative, annually (compared to the $175 fee in Washington, DC). The estimated $1 million in license fees would support the licensing program as well as help support treatment for addiction. When asked if the ordinance was just another way for the city to make money and add to their revenue rolls, Dr. Morita stated it was about protecting the health and well-being of Chicagoans.

Other Efforts

The city of Chicago has long been known to aggressively challenge marketing practices of the pharmaceutical industry, most notably by filing a lawsuit against several opioid manufacturers. In addition to the additional licensing requirement, Emanuel plans to expand investments to treat heroin and opioid addictions, including $700,000 in new funding that will be focused on opioid treatment deserts where there is a disproportionate level of addiction and the need is greater than the availability of services.

Chicago will also invest $250,000 in naloxone, going to the Chicago Recovery Alliance, to increase access to the overdose antidote in the communities that have been hit the hardest by the opioid epidemic.

Focusing on education and awareness of addiction prevention and treatment, Chicago has secured $350,000 for education campaign (including a $300,000 grant from Pfizer and two $25,000 grants from CVS and Walgreens). The education campaign will include outreach to community and to the healthcare providers who prescribe opioids, helping them to understand the dangers of opioid addiction and apply recent guidelines from the Centers for Disease Control and Prevention to prevent overprescribing.

These efforts follow a July agreement between Pfizer and Chicago, where both parties agreed to a painkiller marketing code, which we highlighted in the October issue of Life Science Compliance Update.

Industry Response

The Chicago Tribune reached out to the Pharmaceutical Research and Manufacturers of America, asking for comment. PhRMA had not yet been able to review the details and substance of Chicago’s proposal, noting instead, “Industry interactions with health care professionals, however, are extensively regulated by the U.S. Food and Drug Administration. Patchwork local and state initiatives are likely to disrupt the existing federal regulation of important scientific information that benefits both providers and patients.”

November 11, 2016

A Win for Patients: Prop 61 in California Rejected

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We recently wrote about Proposition 61 in California – a measure that would have required drug makers to provide large discounts to state agencies that serve HIV patients, retirees, inmates, and low-income residents. On Election Day, after months of campaigns (both for and against the Proposition), California voters rejected the measure by a vote of 54% to 46%.

As we have previously noted, the law, while it may sound good in theory, had the potential to force the pharmaceutical industry to raise drug prices for veterans and others who benefit from public assistance programs in California.

Diverse Viewpoints

Known as one of the most expensive ballot propositions in the history of California, proponents pulled out all their stops in an attempt to pass the measure, even airing television ads and bringing Bernie Sanders in to hold rallies in Los Angeles and Sacramento. During a November 7 rally, Sanders closed his remarks by saying Proposition 61 “could be the shot heard ‘round the world,” referring to the domino effect in pricing that the measure’s proponents had been touting. Proponents felt that if they pegged California state agencies to the VA’s price scale for drugs, that it would serve as an example to all state Medicaid programs in the country, and thereby indirectly lower the prices for drugs paid by private insurers.

It wasn’t just the pharmaceutical industry that opposed the measure, however. California citizens who opposed the measure believed that the pharmaceutical companies would have shifted their losses onto the backs of consumers who would not be covered by the measure. Many patient advocacy groups also came out against the measure, as it was entirely possible to them that they settle on drug pricing of medicines that are less costly, more easily accessible, and dangerous to patients.  

Rollercoaster of Polls

As recently as just two months ago, the proponents were ahead by a 2-to-1 margin, according to a USC Dornsife/L.A. Times poll conducted September 1 through September 8. That poll found that a full two-thirds of California voters supported Proposition 61.

Following that poll, pharma and its partners “turned up the heat” and spent an additional $22.3 million in advertising against the proposition. It wasn’t just Pharma that opposed the proposition, however. The California Medical Association, representing the interests of over 43,000 California physicians, as well as essentially every veterans organization, who argued that the measure would have prompted drug companies to boost their prices on veterans, even though federal law protects veterans from price hikes on medicine.

Even in the end, the defeat was surprising to many that were paying attention, especially when you take into consideration that polls taken earlier in the falls showed widespread support for the initiative. The measure was introduced in the midst of the widespread backlash to rising drug prices.

Conclusion

According to Darius Lakdawalla, a health economist at the University of Southern California, “there are so many forces that are aligning for some kind of public policy or regulation on pharmaceutical devices. I don’t think this “no” vote really stops that. There’s too much frustration.”

October 28, 2016

California to Allow Experimental Drug Treatments for Terminally Ill Patients

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California Governor Jerry Brown recently signed legislation allowing terminally ill patients in his state to have access to experimental drugs that have not yet been approved by the United States Food and Drug Administration (“FDA”). This recent stamp of approval stands in stark contrast to his veto last year of a similar bill, then saying that the FDA already has a program in place to allow for the use of experimental drugs and that he wanted to see whether changes in the FDA’s Compassionate Use program would reduce the minimum thirty-day waiting period for experimental drugs.

While the FDA did streamline the process by which patients can apply for expanded access or compassionate use to obtain experimental drugs, the new California law goes even further, allowing patients to entirely circumvent the FDA.

Under the legislation, patients must meet a variety of requirements to qualify for the program, including a requirement that they have only a matter of months to live and that two doctors recommend they try the experimental drug. Additionally, drug makers and device manufacturers would not be required to accommodate a patient’s request for experimental products. It also provides protection for insurers, limiting their liability for outstanding debt related to the treatment if the patient dies.

This legislation is significant, in part because it follows a path that voters in California started twenty years ago: back in 1996, California voters passed Proposition 215 to legalize medical marijuana. According to California Assemblyman Ian Calderon, author of the bill, “terminally ill patients in our state will finally have access to potentially life-saving treatments.”

Around the United States

Right to try legislation has been enacted in thirty-one other states, including Arizona, Colorado, Connecticut, Florida, Georgia, Louisiana, North Carolina, South Carolina, Virginia, and Wyoming, crossing political parties and regional differences. New Mexico is the only state that has not seen a right to try bill introduced. The primary driver behind these laws has been the Goldwater Institute, which offers model legislation to states and their legislators. The model legislation serves as the basis for laws that have been passed in most states.

Tension in the Industry

Though California is the thirty-second state in the United States to enact such legislation, there is still a vocal and tense argument between two camps within the healthcare industry: those who support such legislation, and those who oppose it.

Opposition

Those who oppose such legislation, including oncologists and medical ethicists, believe that access to experimental drugs offers false hope to those with life-threatening illnesses and that experimental drugs have only a limited change of actually working and that pharmaceutical companies have no obligation to offer drugs that are still working their way through trials.

Opposition also notes that Right to Try laws “permit access to experimental drugs after they have passed only Phase 1 trials. At this point in drug development, there is scant evidence about basic safety of the new substance and virtually no data that proves its efficacy in treating the targeted disease. Yet the right to try movement suggests that these early interventions are a magic pill, and that cures are being withheld from dying people solely because of government red-tape or for financial reasons. Even if there were such impediments, the implication that a drug that passes Phase 1 is a cure — and a cure that would not pose substantial risk of pain, injury, or earlier death — is unsupportable.”

Support

Proponents of right to try legislation believe that such laws provide options to patients who cannot wait for drugs to make their way through the FDA’s arduous approval process. According to righttotry.org, “Right to Try Laws give people with terminal illnesses the legal right to use investigational medications years before they might otherwise be on the market. No one can guarantee that a particular treatment will be effective, but these laws return choice and control over treatment options to where it is most effective: with patients and their doctors.”

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