WASHINGTON, D.C. — Patients For Affordable Drugs (P4AD) called on the Federal Trade Commission to investigate a pay-for-delay deal cut by the pharmaceutical giant AbbVie. In a letter to Congress and the Federal Trade Commission, the patient group asked the FTC to investigate whether AbbVie’s recent deal with Samsung Bioepis is anti-competitive and violates antitrust laws.

“AbbVie is using pay-for-delay deals to keep a cheaper generic off the market and patients are the victims,” said David Mitchell, president and co-founder of Patients For Affordable Drugs. “We believe it is illegal and anti-competitive, and we are asking the FTC to step in and protect patients from AbbVie’s price hikes.”

AbbVie announced last week it had signed its second pay-for-delay deal on Humira, guaranteeing the pharmaceutical corporation five more years of monopoly pricing on its blockbuster anti-inflammatory drug. In response, P4AD sent letters on Thursday to the acting chairwoman of the FTC and lawmakers, including leaders of the Senate and House Appropriations Committees.

P4AD also reached out to its nationwide network of patients to encourage them to write their senators in support of changes that would end similar pay-for-delay tactics. As of today, more than 1,200 patients have written to show their support.

Sue Lee, 76, of Crestwood, KY is among the victims of the AbbVie’s unethical dealmaking. Lee has plaque psoriasis, a genetic condition that leads to deep, itchy sores on the skin. She was forced to stop taking Humira after learning  the treatment would cost her $8,000 a year out-of-pocket. AbbVie’s move to extend its monopoly means Lee will have to wait at least five more years for a cheaper version of what she called a “miracle” drug.

The price of Humira has more than doubled in the last five years. Its most recent price increase of 9.7 percent in January 2018 will cost the U.S. health care system $1.2 billion. In pay-for-delay deals, a brand drug corporation pays off a generic drugmaker to stall a generic version of the drug from coming to market, snuffing out competition and keeping prices high.

According to an FTC study, anticompetitive pay-for-delay deals cost consumers and taxpayers $3.5 billion in higher drug costs every year. Since 2001, the FTC has filed a number of lawsuits to stop these deals, and it supports legislation to end such pay-for-delay settlements.
Full text of the letter is below.

+++

Thursday April 19, 2018

Maureen Ohlhausen
Acting Chairman, Federal Trade Commission
600 Pennsylvania Avenue NW
Washington, DC 20580

Dear Acting Chairman Ohlhausen,

My name is David Mitchell, and I am writing as a cancer patient and founder of the organization Patients For Affordable Drugs, the only national patient group focused exclusively on policies to lower drug prices. We don’t accept funding from any organizations that profit from the development or distribution of prescription drugs. I am writing today to urge you, as acting chairwoman of the FTC, to address abusive pay-for-delay tactics used by drug manufacturers to prevent cheaper generic drugs from coming to market.

Pay-for-delay deals thwart the will of Congress and keep drug prices high. Last week, AbbVie announced it had signed a second pay-for-delay deal on its blockbuster drug Humira. According to Axios:

“AbbVie reached a deal with biopharmaceutical firm Samsung Bioepis that prevents Samsung from selling its cheaper copy of AbbVie’s blockbuster drug Humira in the U.S. until June 30, 2023. This settlement comes roughly six months after AbbVie inked a similar deal with Amgen. These settlements guarantee AbbVie will have five more years of monopoly pricing in the U.S. for the top-selling drug in the world, even though biosimilar versions of Humira will be available in Europe this October.” 

Humira is incredibly expensive and costs patients and taxpayers billions. Over the past five years, the price has more than doubled. Its most recent price increase of 9.7 percent in January of this year will cost the U.S. healthcare system $1.2 billion.

We have heard from patients all over the country who are hurt by these pay-for-delay deals.

Sue Lee from Crestwood, KY tells us: “I have plaque psoriasis and had been on Humira for over four years while employed. Since retiring in 2017, I had to stop taking Humira because most of the year it was costing me $5,000 a month. I refuse to almost empty my savings to give to a drug company and have not had an injection since October. There is no cure for plaque psoriasis so this will not go away.”

The Federal Trade Commission (FTC) has said addressing pay-for-delay deals is a priority for the agency. The FTC website reads:

“One of the FTC’s top priorities in recent years has been to oppose a costly legal tactic that more and more branded drug manufacturers have been using to stifle competition from lower-cost generic medicines. These drug makers have been able to sidestep competition by offering patent settlements that pay generic companies not to bring lower-cost alternatives to market. These “pay-for-delay” patent settlements effectively block all other generic drug competition for a growing number of branded drugs. According to an FTC study, these anticompetitive deals cost consumers and taxpayers $3.5 billion in higher drug costs every year. Since 2001, the FTC has filed a number of lawsuits to stop these deals, and it supports legislation to end such “pay-for-delay” settlements.”

On behalf of patients everywhere, we urge you to investigate AbbVie and take appropriate legal action. Patients need your help more than ever to stop this anti-competitive pay-for-delay deal and others like it.

Sincerely,

David Mitchell, President
Patients For Affordable Drugs