Chairman Nadler Statement for the Markup of H.R. 2374, the Stop STALLING Act
Washington, DC, April 30, 2019
Today, House Judiciary Committee Chairman Jerrold Nadler (D-NY) delivered the following opening statement for the markup of H.R. 2374, the Stop Significant and Time-wasting Abuse Limiting Legitimate Innovation of New Generics Act (Stop STALLING Act):
“H.R. 2374, the ‘Stop STALLING Act,’ takes an important step toward lowering drug prices and increasing competition in health care markets. It does this by addressing sham citizen petitions, a delay tactic that some brand-name drug companies use to keep low-cost generic competitors off the market. Sham petitions result in higher drug prices, potentially causing higher mortality among those who can least afford such higher costs.
“The citizen petition process provides an avenue for the public to raise legitimate scientific and health concerns about drugs under review by the Food and Drug Administration. But instead of serving this important function, this process has often been misused by brand-name drug manufacturers to stifle competition from generics and biosimilars. These companies flood the FDA with sham petitions, lacking any scientific or health-related basis, in order to bog the agency down in paperwork and grind the approval process to a halt.
“In one case, Shire ViroPharma, a major biopharmaceutical company, abused the citizen petition process in order to maintain a monopoly over Vancocin Capsules, a drug used to treat potentially life-threatening gastrointestinal infections. For 6 years, ViroPharma inundated the FDA with sham petitions to delay it from approving generic competitors to Vancocin. According to the Federal Trade Commission’s antitrust complaint, ViroPharma’s serial sham petitions ‘lacked any supporting clinical data,’ yet they ‘succeeded in delaying generic entry at a cost of hundreds of millions of dollars to patients and other purchasers.’
“Another appalling example of the use of sham petitions to extend monopolies resulted in dramatically increasing the cost of combatting opioid abuse, a serious nationwide public health crisis. In 2016, together with the Attorneys General of 34 other states, the New York Attorney General filed a lawsuit against Indivior alleging that the drug manufacturer engaged in citizen petition abuse, and other anticompetitive business practices, to maintain its monopoly over Suboxone, a treatment for patients who are addicted to prescription painkillers, heroin, and other drugs.
“According to the complaint, Indivior filed a series of sham petitions to prevent a generic competitor from entering the market with the same Suboxone tablets that it sold and marketed for nearly 10 years at a profit of over $2 billion dollars. By the time the FDA rejected the sham citizen petitions, Indivior had pulled its Suboxone tablet version from the market and had converted the market to its newly patented Suboxone film.
“By abusing the citizen petition process, Indivior reaped monopoly profits from its sale of Suboxone film, and it deprived victims of opioid addiction and medical practitioners the benefits of generic competition. The ‘Stop STALLING Act’ will help put an end to these abusive and anticompetitive practices. The bill provides that the submission of a sham petition to prevent or delay entry of a generic or biosimilar competitor is presumptively illegal under the antitrust laws. It also gives the FTC authority to seek a civil penalty and other appropriate relief in response to the filing of sham petitions by drug manufacturers.
“Importantly, this measure applies only to petitions that are used for anti-competitive purposes as a cover for an attempt to interfere with approval of a competing drug. In doing so, the Stop STALLING Act carefully adheres to existing case law and constitutional principles.
“This legislation strikes a reasonable balance that will help lower the cost of prescription drug prices by preventing unnecessary delays in the approval of lower-cost generic competitors while preserving the public’s right to petition the government.
“I thank my colleagues—Congressman Jeffries and Subcommittee Ranking Member Sensenbrenner—for their leadership on this important legislation and I urge my colleagues to support this potentially lifesaving measure.”