Tagged: FDA

Pharmacies Try Their Hand at Opioid Policy

March 7th, 2018 in Analysis, State Legislation

The opioid crisis has continued to grab national attention, as total drug overdoses hit yet another historic high in 2016.  One of the nation’s largest pharmacies, CVS, recently joined the debate by announcing a new national opioid policy.

In February 2018, CVS started capping new opioid prescriptions at a seven-day supply.  Additionally, CVS is limiting daily doses to 90 morphine milligram equivalents (MME) and requires medical providers to prescribe immediate-release opioids before attempting extended-release versions.  The policy itself is unremarkable.  CVS is merely adopting the CDC’s prescribing guidelines.  In fact, 17 states have done the same or equivalent, including Massachusetts.  And while it may appear strange for a retailer like CVS to forcibly limit its own sales, both pharmacies and pharmaceutical companies have faced a growing threat of litigation in recent years over the marketing and sale of prescription opioids.

Medical providers, chronic pain patients, and some drug policy experts have lodged a number of concerns in response to CVS’s new policy.  These concerns not only identify some of the closely held interests in the opioid debate but also demonstrate the challenges of developing effective policy against a crisis that is rapidly evolving.th

The Costs

Opioid policies fall into three main categories: preventive, treatment, and punitive. The CVS policy aims to prevent the development of new opioid use disorders (OUDs).  In an effort to minimize unintended consequences, the policy carves out two administrative exceptions: first, doctors may request exemptions for certain patients, and second, employers and insurers can opt out of the program altogether.  The CVS policy also aligns itself with CDC guidelines in exempting patients who are in “active cancer treatment, palliative care, or hospice care.”

While this may reassure cancer patients, other patients with chronic pain have expressed cause for alarm.  For one, their access to opioids is already subject to an ongoing and heated debate within the medical community.  Limited data on long-term opioid use for chronic pain management has bisected medical experts’ opinions on the evidence base, ethics, and ramifications of prescribing decisions.  In 2016, the CDC entered the fray.  While its guidelines recommend heavily individualized opioid treatment decisions, the CDC director placed his thumb on the scale by declaring that “[m]anagement of chronic pain is an art and a science. The science of opioids for chronic pain is clear — for the vast majority of patients, the known, serious, and too-often fatal risks far outweigh the unproven and transient benefits.”

Chronic pain patients disagree that the data are so clear-cut.  Moreover, they allege that the national opioid narrative is eliciting a fear-based response among medical providers at a negative cost to their treatment.  Chronic pain patients report that their providers increasingly treat them like “addicts,” an inappropriately stigmatizing term that in these cases also ignores critical diagnostic differences between substance dependency and a substance use disorder.  The result can be forced reductions to a patient’s opioid prescription without warning (known as involuntary tapering) or in extreme cases a blanket office policy against prescribing opioids altogether.  It is early days—too early for clear data in fact—but reports of patient suicides in the wake of involuntary tapering have already surfaced.

opioid-1The CDC does not expressly require a physician to involuntarily taper a patient off of opioids.  In fact, the CDC vests the authority for such individualized prescribing decisions in physicians. However, the DEA, which grants physicians’ prescribing licenses, admittedly muddled that message when it proposed broad cuts to opioid production: a 25% decrease in 2017 and a 20% decrease in 2018.  Moreover, punitive DEA actions against physicians regarding opioid prescription conduct increased fivefold between 2011-2016.  While the penalties are clear and steep (including loss of medical licensure and criminal charges), what conduct triggers those penalties is less clear.  Thus, the combination of liabilities without a clear safe harbor incentivizes an overly strict interpretation of federal policies in ways that may harm patients.

Beyond the legal liabilities, physicians have also voiced concerns over the increasing intrusion of third parties into treatment decisions.  The CVS policy allows a doctor to request exemptions for certain patients, but does not specify its criteria for granting exemptions or if there are caps on the number of exemptions a doctor may request or receive.  Some doctors worry the additional administrative requirements to apply for CVS exemptions will burden already overtaxed primary care physicians, leaving patients with delayed or insufficient care.  For example, one study found that physicians already spend two hours on paperwork for every hour of treating patients.  The CVS policy will increase that paperwork burden for physicians who choose to file for opioid patient exemptions.

Without further research on long-term opioid use, clear safe harbors for prescribing compliance, and a significant increase in the number of medical specialists trained in pain management, some patients and doctors share the concern that this prevention policy will come at unintentional costs to patients with chronic pain.

The Benefits

 Much of policy derives from a cost-benefit analysis.  If prescription opioids are the source of most new cases of OUDs, then some risk to patients with opioid dependencies (like those managing chronic pain) may arguably be worth strictly limiting their supply.  Thus, the $78.5 billion question remains: are prescription opioids presently the main cause of new OUD cases?

A growing subset of drug policy experts say no.  While prescription opioids undoubtedly contributed to the opioid epidemic in the past, recent data show that opioid prescriptions continuously decreased from 2010-2015.  During that same time span however, opioid mortalities continuously increased.  In fact, heroin increasingly represents the initiating opioid of use for new OUD cases, not oxycodone or other prescriptions.  These data suggest that the over-prescription of opioids has been largely corrected and that new and stricter prescription limits moving forward may offer only marginal benefits.

The debate over CVS’s initiative mirrors many of the challenges of developing effective opioid policy at the state level.  The opioid epidemic is rapidly evolving whereas drafting and passing legislation can take years to accomplish.  In that same time span, the drop in prescription rates between 2010-2015 as well as the emergence of heroin as an initiating opioid have shifted the opioid epidemic, throwing into question just recently passed prescription-focused legislation.  In short, the opioid crisis is both testing and demonstrating the limits of the legislative process.

Second, even if a legislature could sustain a multi-decade focus on continually revising opioid legislation, any attempt to do so effectively would require massive data gathering.  Currently however, state medical examiners have already passed their breaking points, whether from running out of room, running out of money, or burnout.  Yet these examiners play a crucial role in accurately identifying the cause of death for overdoses.  Thus, even accurately tracking changes in cause of death alone would necessitate a massive influx of resources, in terms of additional personnel, time, and training for standardization.  Beyond tracking overdoses, states would furthermore have to allocate additional resources to continuously monitor changes in initiating opioid use and to what extent supply limitations (like those currently placed on prescriptions) result in a substitute demand for more harmful illicit opioids like fentanyl.

Third and finally, the unintended effects of legislation matter just as much as the intended.  A complex mesh of societal, punitive, and regulatory forces have created powerful disincentives for physicians to prescribe opioids or treat patients who need them.  In particular, the stigmatization of chronic pain patients incentivizes withholding treatment for moralistic rather than medical reasons.  The threat of criminal prosecution and loss of medical licensure incentivizes avoiding even relatively benign conduct for fear of triggering DEA or state investigation.  Finally, the paperwork barriers formed by each new layer of regulatory compliance incentivize avoiding time-consuming patients, like those who require opioids.  Thus, the exemptions that CVS and other state policies designed to safeguard individualized treatment decisions are likely insufficient to counterbalance the opposing disincentives. Effective policymaking requires a careful calculation of both direct and indirect incentives, far beyond the scope of a single prescription policy.

Going forward, CVS (and the states) should consider policy alternatives that expand provider choices rather than restrict them.  For example, CVS could begin offering the abuse deterrent formulations (ADFs) of opioids.  The FDA recommends ADFs as they offer the same pharmacological benefits as regular opioids but exist in a form that is harder to physically alter for off-label use.  Currently, CVS does not cover any of the ten ADFs approved by the FDA.  By offering a new prescriptive tool instead of restricting an existing one, this alternative might maintain some of the same intended preventive benefits without triggering an incentive to drop chronic pain patients.

Moreover, the addition of ADF coverage would allow for greater flexibility on a state level.  Many states are in the process of or have recently completed crafting comprehensive legislative packages (including combinations of preventive, treatment, and punitive solutions).  CVS’s uniform national policy may interfere with these efforts and make addressing unique state needs more challenging than necessary.

In summary, the benefits of CVS’s opioid policy are unlikely to outweigh its harms.  The CVS policy provides no new guidance as it merely mimics the existing CDC policy, but it does add new layers of time-consuming compliance for providers pursuing medically-valid exemptions.  Pharmacies and other retailers would do better to provide additional support to the existing state and federal opioid infrastructure than begin imposing new requirements upon it.


Scott_Caitlin_U46725303Caitlin Scott anticipates graduating Boston University School of Law in May 2019 and plans to practice Health Law.

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Why Big Pharma Lawsuits Probably Won’t Fix Things

February 28th, 2018 in Federal Legislation, Lobbying, Opinion

By: Lindsey Pasieka

Pharmaceutical companies are sued every single day. There are literally thousands of drug and medical device-related lawsuits going on right now. And they run the gamut, from things like Pradaxa lawsuits, brought on by victims of side effects, to statewide and regional opioid lawsuits, brought on by mayors and state attorneys general. Even government agencies have been known to take Big Pharma to court over violations like dangerous products, and illicit marketing techniques.

So why don’t things change? Why do drug companies continue to hide side effects, market off-label uses and manage to stay out of jail? Well, there’s a few reasons. First, since individual marketers and CEOs are rarely the defendants, the company as a whole has a chance to absorb any penalties- and there are plenty of loopholes to reduce the effects of a guilty verdict. Second, existing laws and regulations favor companies over consumers. And just like with old laws, new laws are hugely influenced by pharmaceutical companies, and more importantly, their money.

They’re Called “Big” for a Reason

FDA approved stamp

FDA approved stamp

One of the biggest pharmaceutical companies in the world is Pfizer. As of 2014, they owned over 500 subsidiaries, and that number is only growing. In 2016, the company has a revenue of $52.8 billion. To put it simply, it is a monster of a company.

That came in handy back in 2005, when the FDA brought an action against the company for its painkiller Bextra. Bextra was approved in 2001 as an alternative to generic options; as a Cox-2 inhibitor, it was supposed to be safer for patients. However, the drug was specifically rejected for approval for post-surgical pain. Despite this, marketers for Bextra deliberately sought out surgeons and marketed the drug for their patients.

Marketing a drug for off-label or unapproved uses is a direct violation of the Food, Drug, and Cosmetic Act (FDCA). So the FDA brought charges against the company. And if Pfizer had taken the hit, the punishment would have meant exclusion from Medicare/Medicaid programs-- and an almost guaranteed financial collapse.

But here’s where being big helps out. Instead of being pinned, Pfizer made a deal so that prosecutors charged their subsidiary, Pharmacia & Upjohn Co., Inc. That company went under, and Pfizer was left only with a fine. Again, being big was beneficial. To a small company, a $1.2 billion bill would be crushing; to Pfizer, it was only 2.5% of their revenue at the time.

The Approval Process Favors Them

Many people think the approval process is too long, too full of red tape and that because of this process that new, desirable drugs can’t get to the patients that need them. When you’re on the outside of the process, it’s easy to understand that point of view. On the inside, though, the pitfalls of our process shine through. Most of those pitfalls are because we try to get things to market faster than every other country, and because money plays a role.

Currently, the FDA must respond to any application for drug approval within 10 months. That’s already outpacing most other countries. But did you know that drug companies can pay the FDA to speed up? The FDA actually has several programs like Priority Review and Fast Track, which companies can pay to get into, which shrinks the approval time to as little as 6 months. This doesn’t include the trials they need to complete before applying for approval, but it does make it difficult for the FDA to make a fully informed decision.

Take, for example, Pradaxa. The drug was submitted to a priority process in 2010, and immediately, the problems with the clinical trials became obvious. The RE-LY trial used a broad population, and excluded the older generations and those with medical conditions that would be most likely to experience side effects. A third-party safety group also discovered that the trial waths not, in fact, a double-blind study. This means that the results pulled from the study are less reliable.

Despite these issues, the FDA pushed Pradaxa through. Some would say this backfired. Within 3 months, the FDA received more serious incident reports for Pradaxa than any drug before it. In its first five years on the market, Pradaxa caused over 1,000 deaths. And it’s now the target of an onslaught of lawsuits, led by victims and their families, and it’s received a black box warning for severe bleeding risks.

Yet, on the flip side, Pradaxa is still a leader on the market for blood thinners, and it brings in billions of dollars a year. So if the lawsuit charges don’t make a dent in revenue, the FDA doesn’t take away approval, and individual employees aren’t charged, why should Pradaxa’s maker change their tactics?

They’ve got Money in Washington

If pharmaceutical companies have some money in the FDA, they have whole banks of it in lobbying. In the first quarter of 2017 alone, the pharmaceutical industry spent $78 million in lobbying. Again, this is a drop in the bucket for companies making dozens of billions a year; but to lawmakers it speaks volumes.

Our example here is the ongoing opioid crisis. Most opioid addictions begin in the doctor’s office, with a prescription. When the pill bottles run out, addicts turn to illegal opioids for a high, most often to heroin. It’s a national issue, and it’s even been addressed by President Trump on several occasions, and declared it a Public Health Emergency. Yet law and regulation changes regarding opioids and addiction are slow to come about.

A big reason is because opioids make pharmaceutical companies money. OxyContin is one of the most prescribed opioids on the market. It is used by millions of people a year, and for many, it saves them from severe, debilitating pain. Evidence shows, however, that the 12-hour drug starts to wear off after 9 hours, causing patients to experience withdrawal between doses. As Oxycontin sales quadrupled between 1999 and 2016, opioid overdose deaths rose to over 200,000-- and counting.

Still, drug makers stand behind their products, and they expect lawmakers to as well. When laws to limit prescribing behaviors were introduced in the House and Senate, Big Pharma pushed back. They went so far as to fund the Pain Care Forum, a lobbying company that spent upwards of $740 million to curb the legislation, and they continue to lobby every time a new motion is brought forward to fight the epidemic.

What We Can Do

Lawsuits don’t seem to work, the FDA falls short, and Big Pharma has Washington in its pocket. While the outlook seems bleak and none of it will be easy to fix, there are ways to improve the situation. 2018is an election year; get out and vote with consumer safety in mind. Find representatives who promise to combat these issues. If your current reps aren’t following through, hold them accountable by calling or writing in. Donate to lobbyists who represent the people, not just large companies.

You can also ask your doctor if they work with pharma reps. You can ask them to explain their medication choices to you, and bring up your concerns regarding painkillers or other drugs with serious side effects. Use your voice to protect yourself, your family and your neighbors, and together, we can work towards change.


LindseyLindsey Pasieka is an investigator and writer who focuses on public health and safety issues. Through her work, she has become an avid advocate for consumers, fighting for their right to safe products. In her role as Consumer Rights Investigator for ConsumerSafety.org, she focuses on health and legal topics that are essential to protecting consumers. In her spare time, Lindsey enjoys reading and spending time with her cat, Lava.

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