Recently, the FDA declared that it was no longer accepting applications for generic formulations of
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| Oxycontin |
The FDA’s determination is sensible. It recognizes the original OxyContin®’s abuse limitations and the attendant public safety risks of allowing generic versions of the original drug to enter the market.
OxyContin® (oxycodone hydrochloride) quickly became the market leader in the burgeoning field of chronic pain management when the FDA approved it for sale in late 1995. Touted for its patented sustained-release properties, OxyContin® allowed patients to obtain 12-hour pain relief, compared with 4 to 6 hours from one tablet of immediate-release oxycodone.
While the drug’s advantages were many, it also had drawbacks. Users or third parties could easily abuse the drug by breaking, chewing, crushing, injecting, or burning it, thereby defeating its sustained release properties and achieving a heroin-like high. By the late 1990s, stories of pharmacies being robbed for the product, and teenagers becoming addicted to it, were rampant. Rural areas in particular saw unusually high rates of prescriptions being written for the drug, and correspondingly high rates of abuse.
Many blamed Purdue for this epidemic and the deaths that resulted. Purdue had aggressively marketed the blockbuster drug, which earned the company over $1 billion in revenue a year by the early 2000s. In a federal criminal case, Purdue officials ultimately pleaded guilty in 2007 – individually and on behalf of the company – to charges that they misled the public about the drug’s risk of addiction and its abuse potential. Other legal battles included hundreds of products liability actions and a robust challenge to Purdue’s patents on OxyContin® brought by a generic manufacturer. While Purdue initially lost at the trial and appellate levels, the Federal Circuit ultimately vacated a finding unfavorable to Purdue, and the company soon settled on terms that protected its monopoly. Meanwhile, Purdue invested millions in creating an abuse-deterrent OxyContin® that is bioequivalent to the original formulation, a feat it achieved in 2010 when the FDA allowed Purdue to replace original OxyContin® with the new formulation, which turns gummy if tampered with. (Full disclosure: I defended Purdue in a patent dispute brought by King Pharmaceuticals in 2008).
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| FDA - The Food and Drug Administration is a federal government agency in the U.S.A that has a mandate to safeguard public safety and health under the Food Drug and Cosmetic Act (FD&C Act) by regulating prescription and over the counter (OTC) drugs, medical devices, combination devices, food, and cosmetics. They have elaborated the regulations around the FD&C Act protecting the public from adulterated and misbranded products in the medical, drug, cosmetic, and food arenas. |
The FDA’s labeling decision recognizes this history. From a practical standpoint, the FDA must incent companies like Purdue to invest in safer products, and its decision to prevent generic entry can be viewed as furthering this objective. From a normative perspective, if a new formulation renders a drug substantially safer than a previous version, the public should not have access to the original, much like one cannot buy new cars without seatbelts. While many individual consumers who used original OxyContin® as intended no doubt would prefer access to it at generic pricing, these desires must be counterbalanced by the real harm that comes to abusers simply from being able to obtain the drug somewhere. Some risks are too great to allow the public to assume them on their own, in the interest of low prices. The FDA’s job is to weigh individual consumer interests in competition against safety considerations that further the public good. In not permitting an open market for an abuse-prone formulation, the FDA made the right decision here.
Purdue Pharma currently sells OxyContin, its patented formulation of the popular pain killer, oxycodone. So popular, in fact, that OxyContin has become one of the most widely abused prescription drugs in history. Entire states, such as Ohio and Kentucky, saw spikes in overall crime rates attributable specifically to OxyContin abuse. Fueling much of the abuse was the ability to crush and snort high-dosage formulations of OxyContin, bypassing the formulation’s time-release effect, and delivering a powerful high. Many abusers described snorting “Oxy” as “better than heroin.” At the same time, for patients with particularly acute pain, physicians have called the medication a “miracle drug,” enabling many sufferers to return to normal, pain-free lives. In total, OxyContin netted Purdue $3 billion a year until 2009.
To Purdue’s credit, beginning in the mid-2000s, it began research into formulations that would prevent OxyContin abuse by making its pills impossible to crush. That formulation was eventually patented and went on the market in 2010. Some evidence has shown that drug-users have found their kicks elsewhere.
But Purdue’s main OxyContin patent, U.S. Patent No. 5,508,042, was set to expire on April 16th of this year, and as such, it faced stiff competition from generics who wished to sell the older, potentially abusable formulation. So, rather than risk any portion of its $2.5 billion market share, Purdue switched the formulation of the “reference listed drug” to the new formulation, and then petitioned the FDA to—get this—declare its previous formulation “unsafe,” even though Purdue had been selling it, hand over fist, since 1995.
Somewhat surprisingly, it worked. On April 16, 2013—the day Purdue’s ’042 patent was set to expire—the FDA announced that “the benefits of original OxyContin no longer outweigh its risks and that original OxyContin was withdrawn from sale for reasons of safety or effectiveness. Accordingly, the agency will not accept or approve any abbreviated new drug applications (generics) that rely upon the approval of original OxyContin.” The end result, of course, is Purdue gets to continue its monopoly of OxyContin under the guise of “patient safety,” while true pain suffers who have never abused this “miracle drug” must continue to pay Purdue’s rents for at least another five years.
Aside from the fact that Purdue seems to have known about and hid information about OxyContin’s potential for abuse from the FDA, there is the issue of what scholars call, “regulatory gamesmanship.” Simply put, using the FDA’s own regulations to peddle a patented and profitable formulation of a drug for years, and then using those same rules to prevent competition by declaring the old formulation “unsafe” has little to do with any real concerns about patient safety and everything to do with profit. For if it did, Purdue would have neither waited until the 11th hour of its patent exclusivity to conduct such research, nor swapped its OxyContin’s reference listing to prevent generic entry.
The public deserves better. OxyContin abuse may have been rampant, but hundreds of thousands Americans—responsible Americans—took the drug to get back to their lives rather than getting high. And of these, most, if not all, were in pain severe enough to take the drug in the first instance. Now that Purdue’s primary patent has expired, they should not be prevented from or pay monopolistic rents to take the exact same drug they’ve been taking all this time. Nor, for that matter, should Medicare and Medicaid foot a continually expensive bill. Drug abusers shouldn’t control the market for generic medications. And nor, for that matter, should regulatory gamesmanship.
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Regulatory work is an imprecise exercise in cost-benefit analysis. No drug would be approved if perfection were the standard. Therefore, the FDA acts appropriately when it acts reasonably, in light of available information. With respect to OxyContin®, unquestionably the FDA’s recent decision meets this standard. When OxyContin® was first approved, the patented extended-release formula offered many benefits to patients suffering from chronic pain. These benefits continued to outweigh the drug’s limitations until a tamper-resistant formulation – with the same positive attributes as the original – was developed.
Creating one was no easy feat, and publicly-available evidence indicates that Purdue did not embark on such research at the “11th hour” in an attempt at “regulatory gamesmanship.” Patents such as Nos. 6,696,088 (filed in 2001) and 7,658,939 (filed in 2003) represent early, good faith efforts by Purdue to address the original OxyContin®’s safety limitations. That these efforts did not immediately bear fruit for Purdue in the form of a commercially viable product says more about the constraints of dosage form design for opioids than it does about Purdue’s intentions. To make a tamper-resistant oxycodone formulation is not difficult. But to make a tamper-resistant oxycodone formulation bioequivalent to the original OxyContin® – so that responsible users in need are not deprived of the extended pain relief of the original formulation – is what took Purdue years of effort and $100 million in research investment to achieve. The FDA’s public safety concerns flow to users and abusers alike.
Finally, it bears noting that consumers who want access to the reformulated OxyContin® at generic prices will not have “to pay Purdue’s rents for at least another five years.” As part of a settlement of a patent dispute between Purdue and Actavis, Actavis will be permitted to offer a generic version of the reformulated drug in 2014. Purdue’s actions in developing, patenting, and marketing OxyContin—and de-developing, re-patenting, and re-marketing the new formulation—are worthy of full-scale, market exclusivity. And the answer, I think here, is a clear, No.
First, it’s critically important to distinguish between the two types of “public safety” at issue here. Neither the drug nor the old formulation is, itself, “unsafe.” The older formulation was only unsafe for recreational purposes. And that is traditionally not the sort of “safety” the FDA is concerned with. Countless prescription drugs are used recreationally, and some, with side effects not present in their “as directed” use. But the FDA does little, if anything, to prevent generic competition of those drugs. Nor should they. We would be appalled if, every time a drug company came up with an abuse-resistant formulation, generics would be precluded from selling their wares.
Second, there were numerous ways to encourage drug companies to develop abuse-resistant formulations of OxyContin, and Purdue clearly took advantage of one of those ways: patents. Purdue’s patents on its new formulations do not appear to expire until 2025—twelve years from now—at the earliest. But patenting a “safer” formulation of drug should only prevent sales of the “safer” formulation, not generics of the older formulation—even if it is abused by some. Physicians concerned about patients who may abuse the drug then have an easy choice—to prescribe, “DAW,” the new formulation. Patients who don’t present such concerns should not be limited in their choice of medication.
Simply put, this just isn’t like cars and seatbelts because it’s not about “public safety”–it’s about regulatory gamesmanship, plain and simple. And Purdue’s actions should be treated like the car wreck they truly are.
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