Pfizer Makes Big News With Small Step In Opioid Class

Congress is moving towards a comprehensive opioid abuse law, while the White House is taking administrative steps to expand treatment for addiction. Pfizer’s agreement on best practices for marketing opioids with the city of Chicago looks like a small step by comparison – but it has big implications.

July 6 was a big day for news about the public policy response to opioid abuse.

The House and Senate conference committee met finalize the Comprehensive Addiction & Recovery Act (CARA), an extensive list of provisions intended to support efforts to curb all aspects of abuse. (Also see "Abuse-Deterrent Formulations Exempt From Medicaid Rebates Under Bill" - Pink Sheet, 6 Jul, 2016.)

At the same time, President Obama announced another series of executive actions to address abuse, including a final rule raising the cap on anti-addiction treatment from 100 patients per physician to 275.

And Pfizer Inc. entered into an agreement with the city of Chicago on a series of marketing rules for opioids that was previewed on the front page of the Washington Post July 6. (Also see "Pfizer Opioid Marketing Agreement With Chicago Follows Help In Suit Against Other Firms" - Pink Sheet, 6 Jul, 2016.)

Given all those choices, the Pfizer/Chicago agreement may seem like an odd choice for the front page. Chicago is big, of course, but this agreement doesn’t even apply to the whole state of Illinois, much less to the country as a whole. And Pfizer itself is a tiny participant in the opioid market — so small that Chicago had not included it in a pending lawsuit against opioid marketers. And the terms of the settlement (as cynics quickly noted) essentially oblige Pfizer to follow its own internal policies on marketing and promotion.

But this is a case where the message is indeed what matters: front page coverage of a company pledging responsibility in the opioid market is exactly what the industry needs. And the fact that it is Pfizer in that role may indicate that the company itself is ready to commit to leadership in the pain category over the long term.

The final rule on anti-addiction treatment will have a more immediate, tangible impact, essentially tripling the market potential for anti-addiction therapies like buprenorphine – albeit with a phase-in based on eligibility and certification milestones for treating physicians.

And CARA has some important provisions for biopharma companies, including a measure exempting abuse deterrent formulations from the Medicaid “line extension” rebate and sections codifying FDA’s opioid action plan. However, those steps essentially ratify and endorse the existing public policy dynamics, leaving the bill to serve primarily as message of bipartisan awareness that opioid abuse is a top-of-mind issue for voters in an election year—but not as any fundamental change in direction in the evolving policy landscape.

That context, though, is what makes the Pfizer/Chicago marketing agreement an important step. It is both a timely move to help assure that the policy response doesn’t turn too sharply into an anti-industry crusade – and also a declaration of Pfizer’s long-term commitment to the pain class.

The perceived failures of FDA and regulated industry are a critical subtheme in the opioid debate –one that, thankfully for biopharma companies, has not been more prominent.  (Also see "The Opioid REMS And Pharma’s Reputation: Slow Uptake May Become Significant Vulnerability" - Pink Sheet, 20 Jun, 2016.)

Having the Washington Post headlines describing an “unprecedented” commitment to responsible marketing was thus a perfect backdrop for the legislative and administrative actions later in the day. The agreement was framed as defining the next level of rules governing marketing of prescription opioids in a fashion similar to the way that industry marketing settlements a decade ago helped defined new rules for gifts to physicians and independent medical education.

And the fact that Pfizer stepped into that role is doubly significant if it in fact signals that Pfizer is committed to the class for the long run.

Pfizer is only a very small player in the broad opioid market, but it clearly has the scale and resources to support the extensive post-marketing monitoring that success in the category is likely to demand going forward. For now, the company markets the abuse deterrent formulation Embeda, and its Troxyca formulation is pending at FDA following a positive advisory committee review June 8.  (Also see "Opioids Need Post-Marketing Data To Inform Abuse-Deterrent Claims, FDA Panel Says" - Pink Sheet, 8 Jun, 2016.)

By getting out in front with a settlement that sets a new benchmark for corporate responsibility, Pfizer is making a different sort of investment in its reputation that could help reassure regulators that it will live up to (and even exceed) their demands for post-market studies and tracking of abuse patterns.

The company is also responding to an invitation of sorts from FDA to do just that: Immediately following the FDA review of the current opioid REMS in May – a review that highlights the degree to which the program is failing to meet its relatively modest goals for prescriber education—FDA Commissioner Robert Califf urged industry to step up to the challenge, and go beyond the demands imposed by regulators.

Purdue Pharma LP remains the largest commercial presence in the class thanks to OxyContin, and—while the company is substantially smaller than Pfizer—its status as a private company shelters it to some extent from the pressure to deliver typical brand name margins to investors. That in turn allows it to invest at a higher level in post-marketing monitoring and studies than might otherwise be the case.

Beyond that, there are not too many companies in the pain category that could match the resources Pfizer could devote to building a long-term franchise in the space. The prominent announcement timed to the other public policy developments amounts to a very public commitment by Pfizer to the category.