INSIDER INSIGHT
What’s The Real Answer to Rising Costs of Blockbuster Drugs? Competition
Ed Price President
PCI Synthesis
The 400 percent increase in the cost of the life-saving allergy treatment EpiPen has gotten its manufacturer, Mylan, into some deep scrutiny – and rightly so. Maybe it’s a combination of greed, market dominance, regulatory requirements and clearly more and more entities taking a share of the profits. Yet this debacle should shed light on the real issue – the need for greater competition to prevent any one company from having a monopoly. It also should shed light on the regulatory environment which supports that monopoly. Although it makes for great political theater, with the media focusing on stuttering company executives trying to justify four-figure price increases or unhinged congressional representatives trying to convince their constituents that they are fighting for John Q. Public, everyone is ignoring the real issue: ever-increasing FDA regulations are preventing new approvals and thus stifling competition.
As with any business, the antidote to one brand monopolizing the market is competition, yet the odds have been in Mylan’s favor when it comes to alternatives to the EpiPen. Auvi-Q, a non-generic competitor, was recalled in October, while generics from major players, such as Teva Pharmaceuticals and Adamis Pharmaceuticals, have been rejected by the FDA. Both companies will have to go back to the drawing board and can’t anticipate launching their generics until at least 2017.
These situations are just a few examples of major global pharma companies with lots of resources and some of the world’s best scientists, who could not pass muster with the constantly changing, ever increasing FDA requirements.
Ed Price is President of PCI Synthesis (
www.pcisynthesis.com), a
pharmaceutical development Contract Manufacturing Organization (CMO) based in Newburyport, Mass. and the largest small molecule
drug substance manufacturer in New England. PCI is also a commercial manufacturer of new chemical entities (NCEs), generic active pharmaceutical ingredients (APIs), and other specialty chemical
products for the medical device industry. As a contract manufacturing organization (CMO), PCI provides emerging and mid-sized
pharmaceutical companies access to the expertise needed to develop and manufacture complex small molecules.
FDA Requirements Need to be Balanced with the Need for a Competitive Marketplace
While rigorous testing and review of new generics must be conducted to ensure their safety and reliability, as well as assurance that they provide a perfect substitute to brand-name drugs, this has to be balanced with the need to get alternative treatments to market.
It’s quite possible that in the case of the EpiPen, if Mylan was seeking FDA ap- proval today, as opposed to in the 1970s, it might not secure it, given today’s
Pharmaceutical Outsourcing | 10 | November/December 2016
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