Life Science Compliance Update

June 29, 2016

Markey Calls for Investigation into Purdue

United States Senator Edward J. Markey has called for a federal investigation of OxyContin's manufacturers in response to a Los Angeles Times report. The report found that the drug tends to wear off early in many patients, which can expose them to an increased risk of addiction.

According to the LA Times, OxyContin's main selling point is that it lasts for twelve hours. The investigation found that "when the effects don't last, patients can suffer symptoms of a narcotic withdrawal, including intense craving for the drug, and experience a cycle of agony and relief that experts say promotes addiction."

The report states that "Purdue has known about the problems for decades. Even before OxyContin went on the market, clinical trials showed many patients weren't getting 12 hours of relief. Since the drug's debut in 1996, the company has been confronted with additional evidence, including complaints from doctors, reports from its own sales reps and independent research."

Allegations included in the report include the idea that Purdue has held fast to the claim of twelve-hour relief to protect its revenue. They allege that OxyContin's market dominance and high price rely on the twelve-hour duration and without such a claim, the drug offers little advantage over less expensive painkillers. The report also alleged that Purdue told doctors to prescribe stronger doses, not more frequent ones, if patients complain that OxyContin doesn't last twelve hours.

In two letters, Senator Markey urged the Department of Justice (DOJ), and the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) to launch probes into Purdue Pharma. As a result of the LA Times report, Senator Markey believes that Purdue made false claims about the longevity of OxyContin's pain relieving properties.

Senator Markey posited that after investigation, if the allegations included in the LA Times report are found to be substantiated, the DOJ should take legal action against the Purdue Frederick Company, Inc., as well as its pharmaceutical subsidiary Purdue Pharma, L.P., including recouping damages that were sustained by federal healthcare programs that paid for excess OxyContin prescriptions that should have been unnecessary if the drug lasted for the full twelve hours, as Purdue claimed.

The letter to the DOJ also cites to a 2007 criminal proceeding against Purdue, in which Purdue "pled guilty to a felony charge of illegally misbranding OxyContin in an effort to mislead and defraud physicians and consumers." In that proceeding, Purdue admitted to illegally marketing and promoting OxyContin by falsely claiming that it was less addictive, less subject to abuse and diversion, and less likely to cause withdrawal symptoms than other pain medications. Purdue agreed to pay over $600 million in civil fines, penalties, and forfeitures in connection with that case. Separately, three Purdue executives pled guilty to misdemeanor charges of misbranding OxyContin and collectively agreed to pay $34.5 million in penalties.

The letter to the FDA and FTC urged the groups to immediately take action that would prevent the dissemination of misleading or false information about OxyContin's duration to those making prescribing decisions, and to patients. Senator Markey also asked the organizations to "warn prescribers, patients, and the general public about the dangerous impact of using higher or more frequent dosing to compensate for OxyContin's failed claims."

Senator Markey's claims and call for an investigation are just the latest in the onslaught on opioid drug makers and opioid abuse. Both the FDA and CDC have changed their prescribing outlines for the drugs; and there is evidence that those changes and the backlash over their widespread use is beginning to cut into sales of the drugs.

Opioid Prescriptions Drop for Three Years in a Row

For the first time in decades, the number of opioid prescriptions in the United States is starting to fall, according to a recent report by the New York Times based on data from IMS Health For each of the past three years – 2013, 2014, and 2015 – prescriptions for opioids have declined. This marks the first sustained drop since OxyContin hit the market in 1996.

Some experts believe that the drop is an early signal that the long-running and often-discussed opioid epidemic may have reached its peak and that doctors and prescribers have begun to heed the warnings about the highly addictive nature of the drugs. It's also possible that state and federal legislation and efforts to curb the epidemic are having an effect.

According to Dr. Bruce Psaty, a researcher at the University of Washington in Seattle who studies drug safety, "[t]he culture is changing. We are on the downside of a curve with opioid prescribing now."

However, the rate of fewer prescriptions has not yet led to fewer deaths – fatal overdoses from opioids have continued to rise. In 2014 alone, more than 28,000 lives were lost from opioids, including prescription painkillers (Percocet, Vicodin, OxyContin) and illegal opioids, such as heroin.

Dr. Nora Volkow, the director of the National Institute on Drug Abuse, believes that "[t]he urgency of the epidemic, its devastating consequences, demands interventions that in some instances may make it harder for some patients to get their medication. We need to set up a system to make sure they are covered. But we cannot continue the prescription practice of opioids the way we have been. We just can't."

Some doctors believe that efforts to rein in prescribing practices have actually gone too far and are penalizing the patients who take the medicines responsibly and need them for relief. Dr. Daniel B. Carr, the director of Tufts Medical School's program on pain research education and policy, stated, "[t]he climate has definitely shifted. It is now one of reluctance, fear of consequences and encumbrance with administrative hurdles. A lot of patients who are appropriate candidates for opioids have been caught up in that response."

Historically, not many physicians prescribed opioids, and those that did often did so aimed at the pain that follows surgery or with terminal illnesses. In the 1990s, however, medical experts began arguing that opioids could be used to treat chronic pain conditions without addicting patients.

Some of the biggest declines in prescriptions have been in the prescribing of hydrocodone. These drugs do remain the most broadly prescribed opioids, especially for following routine dental work or minor procedures. Prescriptions for OxyContin also declined, but those for generic oxycodone went up.

Why the Decline?

One possible factor in the decline is the 2014 regulations enacted by the federal government that tightened prescribing rules for one of the most common painkillers: hydrocodone combined with a second analgesic, i.e. acetaminophen. The first year following the regulation saw a 22% decline in dispensed prescriptions.

The decision by medical schools over the past few years to impress upon students the dangers of opioid prescribing may also have had an effect. Dr. Branson Page, an emergency medicine doctor in Raleigh, North Carolina, stated, "When I was a resident, treating patients' pain as a vital sign was assumed. Now, more of us are aware that even prescribing a small number of opioids to a patient who's never taken them before is rolling the dice on whether that patient will become addicted."

Dr. Jeanmarie Perrone, a professor of emergency medicine at the University of Pennsylvania's Perelman School of Medicine, believes that there may be some danger to the way new doctors are being taught to be overly-cautious when it comes to prescribing opioids. "Sometimes now I will see a patient with a resident who says, 'I don't want to give them opioids.' But of course they need opioids – they have lung cancer and worsening pain."

While there has been a decline, some experts are calling it only a "half victory," believing that the rise of deaths from heroin and fentanyl, are a huge concern that need to be addressed before the opioid epidemic can truly be considered to be slowing down.

June 28, 2016

Senate Judiciary Subcommittee Holds Hearing on CREATES Act

Recently, the Senate Judiciary Subcommittee on Antitrust, Competition Policy and Consumer Rights held a hearing to examine Senate Bill 3056, the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2016. The bill was introduced by Senator Patrick Leahy on June 14, 2016, and targets "abusive delay tactics," such as when branded drug companies use existing Food and Drug Administration (FDA) safety programs and regulations to block the development of generic versions of their products.

At the hearing, senators heard from a panel of witnesses, including representatives from the American College of Physicians, the Consumers Union, the Heritage Foundation, and various academic and industry professionals. Support for the targeted approach of the bill was overwhelmingly supported by both senators and panelists alike.

Opening Statements

All four co-sponsors of the bill delivered an opening statement: Senators Patrick Leahy, Chuck Grassley, Subcommittee Chairman Michael Lee, and Ranking Member Amy Klobuchar. Senator Leahy highlighted two specific delay tactics that are addressed within the CREATES Act: sample sharing (brand-name companies preventing potential generic competitors from obtaining samples of the branded product) and participation in a shared safety protocol (some brand-name companies refuse to allow generic competitors to participate in a required REMS with ETASU protocol, or impose a limited distribution system when a REMS is not necessary, undermining the generic's ability to gain FDA approval.) Under the Act, generic drug manufacturers would be able to bring an action in federal court for injunctive relief, should it find itself facing one of those delay tactics.

Senator Grassley opined that some of the tactics used by brand-name manufacturers may "frustrate the intent" of the Hatch-Waxman Act of 1984, which was enacted to streamline and expedite the approval process for generic drugs. Ranking Member Klobuchar went one step further, noting that some companies' current conduct "threatens the Hatch-Waxman legacy."

Chairman Lee noted that such delay tactics exploit the use of REMS, and that the CREATES Act addresses the issue appropriately, by not piling antitrust law on top of regulation.

Testimony by Panelists

Peter Safir

Mr. Safir, Senior Counsel at Covington & Burling, was the only witness to speak in opposition of the CREATES Act. Mr. Safir shared two major concerns with the bill: (1) safety risks (he noted that "the CREATES Act does not establish robust criteria that eligible product developers seeking to obtain such a drug must satisfy in order to protect patients and other individuals who come into contact with the drug during its distribution") and (2) the 120-day negotiation period, stating that 120 days is a very short period of time and does not take into account the complexity of these proceedings, and such a short time period may have the unintended consequence of encouraging generics to sue brand-name companies rather than engage in shared REMS negotiations.

Beth Zelnick-Kaufman

Ms. Zelnick-Kaufman, Assistant General Counsel at Amneal Pharmaceuticals, testified as to the challenges her company and other generic manufacturers face in obtaining samples and negotiating shared REMS agreements. She cited several examples from her own experience, noting that the CREATES Act provides "essential relief and remedies."

Robin Feldman

Professor Feldman is the Director of the Institute for Innovation and Law at UC Hastings and was able to provide some context to the concerns being discussed, pointing out that the limited distribution system was a tactic used by Martin Shkreli and Turing Pharmaceuticals during the period they were acquiring and raising the price of Daraprim.

George Slover

Mr. Slover, Senior Policy Counsel at Consumers Union, testified about the results of a Consumers Union poll from March, which revealed that among consumers whose out of pocket drug costs are increasing, many will either skip doses or split them, put off doctor's visits, take expired medications, or postpone paying other bills to pay for their medications.

Alden Abbott

Mr. Abbott, the Deputy Director at the Heritage Foundation, believes that the Act would "promote welfare-enhancing competition in the market for brand name pharmaceuticals and biological products (biologics), and their lower-priced generic and biosimilar substitutes, without inappropriately undermining the intellectual property rights of individuals who bring forth new innovative medical treatments that greatly improve the quality of American healthcare" and "would not impose undue burdens on the manufacturers of brand name drugs and biologics."

Dr. Nitan Damle

The only practicing physician on the witness list, Dr. Damle is the President of the American College of Physicians, and voiced support on behalf of himself and the ACP for the CREATES Act and the broad push by Congress to control prescription drug costs.

Discussion

Misuse of REMS and ETASUs

Chairman Lee showed a 2010 PowerPoint presentation, created by an unnamed law firm, that purported to show the pharmaceutical companies how to exploit the use of the FDA safety programs for the purpose of blocking competition and increasing profit. Mr. Safir noted that the PowerPoint seemed to be the work of a law firm who was marketing their services to a pharmaceutical company and should not be attributed to the industry overall. Mr. Safir commented that he does believe a bill like this "might be passed, but with additional protections."

Safety Concerns

Senators asked other members of the panel as to the validity of the safety concerns raised in Mr. Safir's testimony. Professor Feldman noted that the bill explicitly states that jurisdiction over patient safety issues remains with the FDA. Senator Al Franken had a different safety concern, noting that "rising drug prices are causing [his] constituents to forego lifesaving treatments."

Other Concerns

Senator Orrin Hatch (one of the original sponsors of the Hatch-Waxman Act), shared concerns raised by Mr. Safir: he is concerned that a generic could purposely choose to not cooperate during the 120-day negotiation period, or purposely intend to sue a branded company. Professor Feldman stated that she believes the "adequate business justification" required in the bill is enough to protect against such "game playing," while Ms. Zelnick-Kaufman feels that generic companies are economically incentivized to engage in the negotiation, and that it would not be a problem in practice.

Senator Hatch and Senator Thom Tillis both spoke to their support of the intent of the bill, but want to ensure the correct balance is reached: to not disincentivize innovation by branded pharmaceutical companies.

   

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