[Ip-health] Twenty Top Generic Drugs Delayed By Industry Payoffs

Riaz K Tayob riaz.tayob at gmail.com
Fri Jul 12 13:17:20 PDT 2013

[Was a time when USers would rise up against monopolies and trusts... 
but now, they seem to know their place... perhaps if congressmen and 
women wore jackets like NASCAR sponsors it would make politics more 
manageable... 40 million Americans without healthcare, mostly black and 
hispanic... ]

July 11, 2013
10:31 AM


*CONTACT: US PIRG <http://www.uspirg.org>*

Laura Etherton, U.S. PIRG, 971-266-2453 
etherton at pirg.org <mailto:etherton at pirg.org>
Kathy Melley, Community Catalyst, 617-791-0708 
kmelley at communitycatalyst.org <mailto:kmelley at communitycatalyst.org>

    Twenty Top Generic Drugs Delayed By Industry Payoffs

      New Research Shows People with Cancer, Heart Disease, Other
      Serious Conditions Forced to Pay 10 Times More Than Necessary for

WASHINGTON - July 11 - Americans with cancer, heart disease, epilepsy 
and other conditions have been forced to pay an average of 10 times more 
than necessary for at least 20 blockbuster drugs, according to a report 
released today by Community Catalyst and the U.S. Public Interest 
Research Group (U.S. PIRG).

The report, "Top Twenty Pay-for-Delay Drugs: How Drug Industry Payoffs 
Delay Generics, Inflate Prices and Hurt Consumers 
<http://uspirg.org/reports/usp/top-twenty-pay-delay-drugs>," reveals 
that these drugs were subject to an industry practice called "pay for 
delay," in which brand-name pharmaceutical companies pay off generic 
drug manufacturers to keep lower cost equivalents off the market, 
forcing consumers to pay higher brand-name drug prices.

The top 20 list comes after the U.S. Supreme Court ruled that 
pay-for-delay agreements may be illegal under antitrust law.

"It's outrageous that drug companies are paying off the competition to 
keep prices high," said Laura Etherton, U.S. PIRG health care policy 
analyst. "Because of this, Americans pay inflated drug prices, or go 
without necessary medication. This needs to stop."

Pay-for-delay deals have postponed as many as 142 generics from coming 
to market, according to Federal Trade Commission (FTC) reports. But 
since the details of these deals rarely become public, consumers have 
been largely kept in the dark about the problem.

"These 20 drugs from the report are just the tip of the iceberg," said 
Wells Wilkinson, Director of Community Catalyst's Prescription Access 
Litigation Project. "These schemes by the drug industry have forced 
consumers to pay billions more for just these 20 drugs. How many 
generics of other 'blockbuster' drugs have been kept out of reach by 
these backroom deals? How much has pay for delay cost consumers overall?"

Karen Winkler found out about the issue the hard way. A pay-for-delay 
deal made it harder for her to access the medication she needed for her 
multiple sclerosis-related fatigue. "I needed Provigil just to function, 
but it cost me $500 a month out-of-pocket, even with insurance," she 
said. "For years, I'd skip pills or split doses just to get by, and 
eventually had to stop taking my medicine because I could no longer 
afford its high price."

Pay-for-delay deals blocked the generic version of Provigil for six 
years, until last October. Karen now pays a $16 co-pay every three 
months for the medication. "I'm back to living my life," she continued. 
"But no family should have to go through what we did."

Key findings of the report:

    . Pay for delay has held back generic medicines used by patients
    with a wide range of serious or chronic conditions, ranging from
    cancer and heart disease to depression and bacterial infection;
    . Payoffs have delayed these 20 generic drugs for five years on
    average, and as long as nine years;
    . The top 20 brand-name drugs cost an average of 10 times more than
    their generic equivalents, and as much as 33 times more; and
    . Combined, brand-name drug companies made an estimated $98 billion
    in total sales of these 20 drugs while the generic versions were

Key drugs highlighted in the report include:

    . Tamoxifen: People with breast cancer waited nine years for generic
    competition to bring down the cost of this drug, a widely used
    treatment for hormone-receptive breast cancer, due to a
    pay-for-delay deal.
    . Lipitor: People with high cholesterol pay as much as $205 for a
    30-day supply of Lipitor. Now that the generic version is available,
    it costs $18. During the time the generic was delayed, Pfizer made
    $7.4 billion in sales of Lipitor in the last year alone.
    . Lamictal: People with epilepsy can pay as much as $465 for
    brand-name Lamictal -- 33 times the price of the generic, now that
    it is finally available. Pay for delay postponed the generic for
    three years.
    . Cipro: The brand-name version of the antibiotic Cipro can cost
    $346 for the most commonly prescribed quantity, while the generic
    costs just $23. Bayer made a deal with generic drug makers to delay
    the drug for seven years.
    . Provigil: Many multiple sclerosis patients and others faced paying
    up to $1,200 a month for this drug because the brand-name
    manufacturer, Cephalon, paid four different generic drug
    manufacturers a total of more than $200 million to keep the generic
    version off the market until 2012.
    . Pay-for-delay deals are currently blocking generic versions of at
    least five drugs: Aggrenox (stroke prevention), Niaspan (high
    cholesterol), AndroGel (synthetic testosterone), Nuvigil
    (narcolepsy), and Nexium (heartburn and GERD).

The Supreme Court ruling is likely to lead to further legal challenges 
to pay-for-delay deals. But while litigation may ultimately help 
consumers recover some of the unfair costs these deals have caused, 
consumer advocates are calling on Congress to finish the job and pass 
legislation to put a stop to the practice.

"Consumers have been stuck paying more than they should have to for 
needed medication. Now, they're looking to Congress to put a stop to 
this practice," said Etherton. "Lawmakers should end these drug company 
shenanigans that inflate drug prices and hurt the people that rely on 
prescription drugs."

There is bipartisan support for ending pay for delay. Sens. Amy 
Klobuchar (D-MN) and Chuck Grassley (R-IA) are sponsoring S.214, the 
Preserve Access to Affordable Generics Act. The bill declares that 
pay-for-delay deals are presumed anti-competitive and unlawful, and it 
authorizes the FTC to enforce the law by initiating proceedings against 
companies that participate in such deals.

Sens. Al Franken (D-MN) and David Vitter (R-LA) are sponsoring S.504, 
the FAIR Generics Act. The bill reduces the incentive for generic and 
brand name drug companies to make pay-for-delay deals by letting a 
second generic drug company enter the market if the first generic 
company takes a pay-for-delay deal.

Download the report here. 


U.S. PIRG, the federation of state Public Interest Research Groups 
(PIRGs), stands up to powerful special interests on behalf of the 
American public, working to win concrete results for our health and our 
well-being. With a strong network of researchers, advocates, organizers 
and students in state capitols across the country, we take on the 
special interests on issues, such as product safety,political 
corruption, prescription drugs and voting rights,where these interests 
stand in the way of reform and progress.

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