Politics and drugs

March 12, 2015
Pharmaceutical Commerce, Pharmaceutical Commerce - March/April 2015,

Medical marijuana and biosimilars are two topics where 'the will of the people' push decisions

There are two topics in this issue that, in large part, have broad political (as opposed to economic or philosophical) underpinnings, and interestingly, it’s hard to put them on the usual left/right, Democratic/Republican spectrum. The two are medical marijuana and biosimilar regulation. Neither has an inherent connection to the other; but both represent a series of choices—and decisions—by the US public and its leaders to reconcile differences by making a political choice, with the proponents and opponents each coming the others’ way.

With marijuana, the societal choices have been fairly obvious. After more than a half-century of trying to keep it away from consumers, state governments have realized that the medical applications are the wedge that enabled a consumer marketplace to arise. (It’s interesting to note that until the late 1940s, there were several mainline pharma companies selling cannabis-based healthcare products.) Many US states now allow for some distribution of it; some have gone the whole way toward allowing limited recreational use. And while there have been a handful of synthetic cannabinoid products on the market, there is a body of evidence pointing to some advantages of the plant-derived versions. So: plant-derived cannabinoids are now an established market, but there are still many constraints on widespread use of them. Our report finds that the existing drug-distribution industry—wholesalers, pharmacies and hospitals—are still keeping a wide gap between themselves and the medical marijuana business. (The lack of a uniform federal mandate is the biggest obstacle.) That gap will be bridged first, it seems, by pharmacists and medical doctors. Going forward, either medical marijuana will become a normal part of healthcare products distribution, or it will grow into some kind of parallel industry, located roughly where a lot of other natural food and wellness products distribution occurs today.

The biosimilars topic represents a similar range of choices—just that there’s evidence that it’s being crippled by the current regulatory regime. For more than three decades (since the Hatch-Waxman Act), the “grand bargain” of the pharma industry and American society has been: Industry gets to keep an unrestricted national pricing scheme; society gets to have generic products. But biosimilars—authorized nearly five years ago now, but without a functioning regulatory process to this day—are being fought by the innovator companies at every turn. The issues at the moment are: how much clinical trial testing needs to replicate the trials of the innovator products, and whether biosimilars can have the same labeling as (and thus be interchangeable with) the innovator product. And this is despite the growing body of evidence, from biosimilars’ track record abroad, that the products are effective and can be regulated more or less like small-molecule generics.

Biosimilars are not going away. The trend here points to two outcomes: Either industry stops fighting tooth and nail to prevent biosimilar introductions, or, at some point, the entire pharma pricing and market-access structure comes crashing down. Medical scientists will argue the pharmacokinetics and economists will argue the financial costs and benefits of biosimilars for years to come, but politicians will be making decisions in the not-too-distant future.

Calling a decision “political” is usually a way of denigrating it—to imply, in some fashion, that a backroom deal was struck in opposition to the voice of a significant portion of society. But the pattern over the past decade of medical marijuana legalization has been one of support from patients’ rights groups, states’ rights advocates and general frustration with the problems of law enforcement in the so-called “war on drugs.” With biosimilars, public opinion is muted, probably over the complexity of the debate. But the frustration that consumers have with drug prices is growing louder. Industry is taking a big risk with its resistance to biosimilar commercialization.