Late last year the FDA approved a powerful painkiller called Zohydro – a pure hydrocodone drug. And immediately there was a swell of backlash because the drug’s manufacturer had not developed a tamper-resistant packaging solution for it. Without the tamper-resistant packaging, critics argued that the FDA was ignoring the high potential for opioid abuse and the ramifications that came along with that.
One critic (among many) was Massachusetts state governor Deval Patrick, who announced he was banning Zohydro from his state until its maker Zogenix developed an abuse-deterrent version. In lock step with the approval of Zohydro, the FDA had approved a new treatment called Evzio which contains one dose of naloxone, a drug used by doctors and medics to reverse the effects of an overdose. Approved ahead of schedule, the product is special in that it is an EpiPen-like handheld device that can easily be used by family or friends of people known to abuse opioids or heroin. It has a retractable needle and would be used on someone who has stopped breathing or lost consciousness from an overdose. So, Patrick announced that his government was immediately making Narcan (the brand name for naloxone) available on an ‘expanded use’ basis to all first responders.
Do states have the ability to point to FDA panel recommendations as a lever to restrict access to drugs?
Pre-emptive mechanisms
But the issue here is not about whether opioid abuse is an important social issue or an epidemic that is worthy of our attention. Clearly it is. The issue is not about whether manufacturers, clinicians, advocacy groups and public health officials have to work together to solve this problem. Of course they do.
There are really two issues to me that are fascinating about this case study: why did the FDA approve this drug when its own expert panel voted overwhelmingly not to allow it on to the market and how can we reconcile ourselves to the fact that there might be a pre-emptive mechanism available to individual states that have a concern with the FDA’s drug approvals that allows them simply and unilaterally to ‘not make a drug available’.
On the second issue, a US district judge has already upheld an injunction filed by the drug’s manufacturer that temporarily halts the ban on the prescription and sale of Zohydro. So Zohydro is now available in the state of Massachusetts. The move by Governor Patrick represents a slippery slope and one that the judge quickly closed. We can only imagine the future pleas of states that look to avoid making critical therapies available and to restrict access to drugs on financial, clinical or policy-related grounds. Where would it end? Or would it? And where would that leave patients and providers – apart from being caught in the crossfire.
But the interesting juxtaposition to this issue is the fact that the FDA’s own Anesthetic & Analgesic Drug Advisory Committee (ie expert panel) voted against making Zohydro available. And it wasn’t close. It was 11-2 against approving Zohydro. The expert panel cited ‘achievement of narrow targets for safety and efficacy’ and the potential for abuse as the main reasons for overwhelmingly voting against approval. So, now we ask ourselves why the FDA decided to approve the drug anyway. Other than an unmet need in the chronic pain market for patients who are uncontrolled on current therapies, there doesn’t seem to be an obvious answer. And don’t get me wrong: that’s a fine reason to approve a drug – but a reason that could apply to any drug in any therapeutic class, no? There are millions of patients on current classes of therapies across a variety of disease states that are uncontrolled and, yet, the FDA does not routinely rubber-stamp approvals of new drug classes – especially when their own advisory committees recommend against it. And, yes, I understand that ‘those’ new drug classes don’t have the same issues with abuse as powerful opioid pain killers do. But still, this does seem odd.
Restriction levers
Herein lies the rub with Governor Patrick’s aggressive move to ban the prescription and sale of Zohydro in the state of Massachusetts: at what point (or is there a point) do states have the ability to point to the FDA’s own expert panel recommendations as a lever to restrict access to drugs either on the grounds of safety or efficacy? If the FDA approved Zohydro and it did so based on the unanimous recommendation of the Anesthetic & Analgesic Drug Advisory Committee, there would likely be significantly less discussion on this issue. But if you ask a group of experts to give you an opinion and 85 per cent of them tell you not to do something and you go ahead and do it, you leave yourself open for this type of questioning.
It would set a dangerous precedent to allow states to circumvent FDA drug approvals, period. Many are not in favour of it and cite the adoption of restrictive prescriptions (ie no refills), better education at both the primary care and patient level on the dangers of abuse, surveillance and registries to track narcotics and controlled substances, and the full involvement of manufacturers in this problem as mechanisms to deal with nascent issues such as this one.
