Life Science Compliance Update

« May 2016 | Main | July 2016 »

35 posts from June 2016

June 30, 2016

Alliance for Health Reform Holds Biosimilar Panel

The Alliance for Health Reform recently held a briefing on biologic drugs and the emerging market for biosimilar products in the United States. The briefing allowed for a discussion of regulatory and policy questions that continue as the Food and Drug Administration (FDA) continues to review and approve applications for biosimilars. As of right now, the FDA has approved two biosimilars, but only one of those two approvals is available on the market.

The panel discussion included experts such as: Leah Christl, the associate director for therapeutic biologics at the FDA; Barbara Finck, the chief medical officer at Coherus Biosciences; Brian Lehman, the manager of pharmacy benefits and policy at the Ohio Public Employees Retirement System (OPERS); Leigh Purvis, director of health services research at AARP; and Angus Worthing, rheumatologist and member of ACR Government Affairs Committee, American College of Rheumatology.

Panelists represented a wide range of stakeholders and throughout the discussion, panelists talked about public acceptance of biosimilars, the costs of biosimilars (as well as potential for savings), and lingering regulatory issues such as standards for interchangeability and non-proprietary naming requirements.

Discussion Points

Interchangeability Standard

Leah Christl discussed what type of data will be necessary to demonstrate a biosimilar's interchangeability with its reference product. She noted that we are dealing with uncharted waters here, as the United States is the only country to actually differentiate between biosimilarity and interchangeability. She stated that interchangeability is a different standard, but not necessarily a higher standard. She, however, stopped short of giving specific data elements that will be required, noting that no guidance has yet been published.

She offered the suggestion to look to the statute, to see the types of information that might be necessary. She further noted that the information did not have to necessarily be clinical data, and can include elements from post-market analysis. The agency will consider the "totality" of the circumstances, avoiding a "one size fits all" approach.

FDA Regulatory Efforts

While it may seem like it is taking a long time for the FDA to do much of anything about biosimilars, it is important to remember that there are several pieces to the puzzle that need to be put together. According to Dr. Worthing, full transparency is key: it will allow patients to know what they are taking and will provide physicians with the information they need to know about what they're prescribing. He believes that "this can be accomplished by using distinct names for biosimilars, having clear information on FDA drug labels, and implementing consumer-oriented pharmacy dispensing practices."

Biosimilar Development

Barbara Finck spoke on biosimilar development, acknowledging that biosimilars have the same amino acid "backbone" as their reference drug, but as they are made of living cells, they have small differences as a result of manufacturing. Dr. Finck equated it to an expert forger making copies of the Mona Lisa, each copy would be very good, but there would still be small differences between the copy and the original; Dr. Christl equated it to brewing beer: the fermentation process can render each batch slightly different that the one before it, even though they always start with the same ingredients.

Public Acceptance of Biosimilars

The panelists generally discussed how important it is for the biosimilar market to be thriving: Leigh Purvis noted that it may be important for patients to fully understand that there is nothing to fear about biosimilars, and that they would (on average) save patients 25% to 30% as opposed to the reference product. Biosimilars, therefore, may be a solution to the contentious drug pricing topic frequently discussed these days.

Dr. Finck also agreed that biosimilars are safe and effective: she referenced stringent FDA statistical standards and the European experience. Biologics and biosimilars are expected to be covered under Part D.

Conclusion

In the end, Dr. Worthing noted, "It's easy to get lost in the weeds of regulatory issues, but biosimilars naming, labeling and interchangeability issues have real and profound safety and health consequences for patients."

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.

Newsletter


Preview | Powered by FeedBlitz

Search


 
Sponsors
March 2017
Sun Mon Tue Wed Thu Fri Sat
1 2 3 4
5 6 7 8 9 10 11
12 13 14 15 16 17 18
19 20 21 22 23 24 25
26 27 28 29 30 31