The EpiPen Episode’s Silver Lining

In the long run EpiPen’s widely publicized pricing imbroglio may result in more political support for today’s wobbly life science commercialization. Its two pillars – patents and pricing predictability  – are presently under attack from anti-patent advocates and price control activists who typically rely for support on prevalent public ignorance of patent law arcana, drug pricing’s complexity and politically motivated congressional apathy. But fueled by social media, public outrage has triggered a public airing of EpiPen’s retail pricing dynamic. The increased press coverage has been very informative. Drug pricing’s many influencers have been so obscured by the distribution chain’s convoluted entanglements, third party payment systems and press laziness, its multi-faceted beneficiaries have been operating without much public awareness. As a result, it has been easier for price controllers and anti-patent activists to focus lawmakers’ sole attention on highly visible retail drug prices rather than taking time to understand the influence of the many contributory components underlying them. Because of the EpiPen episode’s extensive press coverage, much of the public and even the press now better understand why eliminating patent protection and single solution price control “cures” for abusive pricing of prescription drugs will impair future drug development, they will miss the mark, and will do more harm than good.

The EpiPen’s pricing publicity has injected wider interest and transparency into the complex drug pricing issue. Public outrage has pierced the clouds obscuring prescription drug pricing, enabling a silver lining of increased public understanding to emerge. Through social media and front-page news coverage (like Andrew Pollack’s excellent New York Times piece), we are being tutored in plain language on the pricing and distribution contributions made by: increased health insurance deductibles and co-pays, pharmacy benefit managers, drug retailers, Medicare “donut holes,” Affordable Care Act Exchange abandonments, physician prescription directives, consumer discount and coupon rigmarole, generic pricing practices and even the slow-moving FDA. Echoing familiar misuse of anecdotal patent troll abuses, anti-patent advocates and prescription drug price controllers have focused lawmaker attention on admittedly abusive conduct by a few drug manufacturers in order to blame high prices solely on patents and/or to install price controls on all prescription drugs. Now the press is engaged, the public is paying attention and lawmakers can no longer vote blindly while hiding behind their “busy schedules”. In short the real issues affecting life science commercialization have attained new political priority. And not a moment too soon.

An over-narrow anti-patent directive is now driving Ban-ki moon’s UN High Level Panel on Medicinal Access to issue an oversimplified, misleading final Report. The Panel either must reach beyond its confining anti- patent premise or reach a dangerously narrow anti-patent conclusion. Colombia, Thailand, India and other nations advocate compulsory licensing. The issue even has publicized voluntary and involuntary U.S. subsidization of world health care. Here at home, EpiPen hullabaloo has highlighted the madness of mindlessly imposing priced-based Bayh-Dole march-in and other silver-bullet pricing solutions on a life science commercialization dynamic already enervated by SCOTUS and the America Invents Act. EpiPen’s social media explosion has all but preempted the recently initiated “Campaign for Sustainable RX Pricing” quest for more public dialogue about prescription drug pricing. But most important, it has made politicians grapple with the issue, forcing them to face-up to the folly of continuing their decade-long budgetary flat-lining of NIH, CDC and FDA budgets, while Zika creeps across the Gulf Coast, cancer moonshots are unfunded, Ebola spreads, precision medicine initiatives flounder and drug-resistant superbugs lie in wait at our local healthcare facilities while partisan wrangling over socially contentious “life/choice” issues prolongs inadequate support to contain actual ongoing carnage.

EpiPen’s eruptive timing was important. Had Congress been in town, lawmakers would have filled the front pages with populist blather. Had Mylan been less forthcoming about the retail drug supply chain, the press would have been less likely to look into its composition. Had Mylan’s CEO not been a sitting Senator’s daughter, gossipy Hill reporters would have been bored. If health insurer withdrawals from ACA exchanges had not led to higher consumer costs and rates to match, and most important, if anaphylaxis did not simultaneously threaten the lives so many children and bust the back-to-school budgets of more than 15 million middle American families, the multi component drug pricing issues might have been buried on news papers’ back pages. EpiPen pulled these issues out of hiding into the light of public concern where oversimplified self-serving solutions tend to wilt.

The fact is we have been treated to a highly publicized health pricing tutorial using a live case study to learn about the many drivers of retail drug pricing. Yes, the EpiPen increases happened,  and yes other abuses will  happen again. But the public and the industry both are wiser to the political power of social media coupled with parental outrage. There likely will be congressional hearings. Predictably they will feature more  bloviating than information. But this elevated awareness will definitely ease explaining the life science innovation ecosystem to lawmakers, the only way to save life science research commercialization and its medical and economic public benefit from destructive interference. Consensus green shoots are emerging . Press coverage now reiterates that competition is the key to containing prescription drug pricing.  Price abuse is possible only where competition is impossible. And where such is the case, public outrage channeled through social media can contain it. None of these constraints will cripple life science commercialization. Misguided sweeping congressional imperatives will.

Much needed innovative drugs cannot be developed without limited, but reliable, patent protection. Where these two commercialization pillars are appropriately balanced, reasonable pricing will follow. Where market demand is such that they are out of balance and public pressure fails to exert its containment capacity, comprehensive stakeholder dialogue is needed. Even within this narrowed arena such discussions will take time, but time spent conducting it will be time spent wisely. Meanwhile the safest and smartest short road to successfully managing retail drug costs will be to encourage and enable more competition by pressuring Congress to do its job by adequately funding NIH, CDC and FDA so they can do their jobs. In light of present needs is no longer politically defensible to prolong the decade-long budgetary compression of these agencies, whose very purpose is to carry out existing congressional directives enacted to timely respond to public health needs and to encourage life science innovation and reasonable pricing while striking appropriate balance between their conceptual cross purposes .