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TRENTON-New Jerseyans 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 the New Jersey Public Interest Research Group (NJPIRG) and Community Catalyst.
The report, “Top Twenty Pay-for-Delay Drugs: How Drug Industry Payoffs Delay Generics, Inflate Prices and Hurt Consumers,” 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.
“It’s outrageous that drug companies are paying off the competition to keep prices high,” said Jen Coleman, NJPIRG Advocate. “Because of this, people in New Jersey pay inflated drug prices, or go without necessary medication. This needs to stop.”
The top 20 list comes just weeks after the U.S. Supreme Court ruled that pay-for-delay agreements may be illegal under antitrust law, opening the drug industry to lawsuits over the deals. Michael Carrier, Distinguished Professor at Rutgers Law School—Camden explained: “The Supreme Court has recognized that these concerning agreements can have anticompetitive consequences and can lack any legitimate justification. By making it clear that cases challenging these practices as antitrust violations can proceed, the Supreme Court has helped to ensure that U.S. consumers have the benefit of true competition and lower prices.” (Professor Carrier was co-counsel on an amicus brief filed in Actavis on behalf of 118 professors of law, economics, and business.)
However, the Court chose not to declare all such payoffs unlawful, prompting consumer advocates to call on Congress to finish the job and pass legislation to put a stop to the practice. 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.
“Too many families, parents, and grandparents are faced with deciding between buying a needed medication or food,” said Nina Radcliff, MD, an anesthesiologist. “I recently sent my patient to the emergency room for dangerously high blood pressures that could have given her a heart attack or stroke. She had changed her hypertension medication three weeks back because it was too expensive,” said Dr. Radcliff.
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. Cipro is manufactured by Bayer.
• 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).
“These top 20 are the tip of the iceberg,” said Wells Wilkinson, Director of Community Catalyst’s Prescription Access Litigation Project. “To put this list together, we combed through the information that has been made public thanks to consumer class action lawsuits, legal challenges brought by the FTC, research by legal experts, and public disclosures by drug makers.”
Key findings of the report include:
• 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 delayed.
“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 Coleman. “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 anticompetitive 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.
Senator Menendez and Chiesa have important roles to play in advancing efforts in Congress to end the practice of pay for delay. Neither senator is currently a co-sponsor for these bills. We urge both Senators to support these bills, and help end pay for delay.
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NJPIRG, the New Jersey Public Interest Research Group, is a nonprofit, nonpartisan public interest advocacy organization that takes on powerful interests on behalf of its members, working to win concrete results for our health and well-being. www.njpirg.org.
Community Catalyst is a national, nonprofit consumer advocacy organization that works in partnership with national, state and local organizations, policymakers, and philanthropic foundations to ensure consumer interests are represented in communities, courtrooms, statehouses and on Capitol Hill. The organization’s Prescription Access Litigation project has challenged the pay-for-delay deals blocking consumer access to affordable Provigil, Cipro, K-Dur, and Tamoxifen. www.communitycatalyst.org.
Nina Radcliff, MD may be contacted for additional comment at email@example.com, or (215) 400-1793.
Michael Carrier, JD may be contacted for additional comment at firstname.lastname@example.org, or (856) 225-6380.
Download the report at http://njpirg.org/reports/njp/top-twenty-pay-delay-drugs
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