Shire's Unlawful Monopoly Directly Harmed Consumers Taking Adderall

Adderall manufacturer, Shire Pharmaceuticals, can't seem to stay out of trouble with the FDA and consumers. In October 2014, the company settled claims of deceptive marketing for more than $56.8 million. The settlement was in response to allegations that Shire inappropriately promoted the sale of Adderall, a drug for ADHD and ADD, by advocating the drug for off-label use-despite lack of clinical data to support those claims. Shire not only stated that competitor's ADHD medications could not achieve similar results, but also that Adderall XR was "clinically superior to other similar drugs because it would normalize its recipients." The lawsuit was brought by attorney generals in each U.S. state.

Shire's Pay-For-Delay Deals

Unfortunately, this settlement may be only the tip of the iceberg as far as Shire's history of padding profits at the expense of consumers. In 2012, Adderall topped the list of twenty drugs which adversely impacted consumers due to pay-for-delay deals. Pay-for-delay agreements are a form of patent dispute settlement agreements in which a generic manufacturer acknowledges the patent of the original pharmaceutical company. The generic manufacturer then agrees to refrain from marketing the generic for a specific length of time. In return for this agreement, the original pharmaceutical company pays the generic company an agreed-upon sum of money.

Pay-for-delay deals can delay generic drugs for three to five years on average, and, in some cases, as long as nine years. Brand name drugs cost as much as ten times their generic equivalent on average, and sometimes as much as thirty-three times more. The twenty companies listed as biggest offenders have made more than $98 billion in total sales of their drugs while the generic versions were being delayed. Shire inked their pay-for-delay deal in 2006, for a period of three years.

Shire Shifts Gears, Allowing "Authorized Generics"

Once the pay-for-delay deals ran out, Shire changed its tactics, reaching settlements with the same companies they had previously tried to squeeze out of the market. These settlements allowed the generic companies to introduce "authorized generics," in return for royalty payments made to Shire. Even this, apparently, was not enough for Shire, as the company failed to provide the generic companies with enough product to meet demand, ensuring consumers could not purchase generic versions of Adderall XR. In any case, from 2006 to 2012, Shire maintained their hold on the Adderall market through one tactic or another. Finally, in 2012 and 2013, the first two unauthorized versions of Adderall generics were approved by the FDA.

The FTC has challenged pay-for-delay agreements in court, on the basis they violate United States antitrust laws, which protect consumers by allowing them to purchase cheaper generics of expensive drugs. The Senate has looked at prohibiting the pay-for-delay practices altogether. Shire points to the Hatch Waxman Act of 1984 which, among other provisions, offers a thirty-month stay to drug companies that file suit against generic manufacturers who challenge their patent. The Hatch Waxman Act has become controversial because of companies like Shire who manipulate the system to prevent generics from taking a piece of "their" profits.

Shire Attempting to Introduce a New Version of Adderall XR

When Shire entered into the three-year pay-for-delay deals back in 2006, they wasted no time. The pharmaceutical company developed a new form of Adderall which would last 16 hours, requiring only one dose per day. This drug contained the same active ingredients as Adderall XR, however Shire has run into a few stumbling blocks in obtaining FDA approval of the drug. In April, 2014, it appeared as though Shire's new ADHD drug would finally be approved, but very recently, the FDA demanded further studies on the drug, particularly as it relates to children. Anti-trust lawsuits have been filed against Shire in Florida, Pennsylvania, and California on behalf of consumers who were unable to purchase generic versions of Adderall XR due to Shire's delaying tactics.