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.