Generic drug entry into the marketplace is one of the most effective ways to lower overall pharmaceutical costs. Brands using bad faith tactics like exclusion payments, regulatory abuse, product hopping and other anticompetitive conduct to forestall generic entry is problematic.

Amicus Briefs

News

Generic Drugs Save Lives Like Mine. This Bill Will Help Make Sure They're Available - By Cynthia Stockton 9.3.2019

 

California Bill Would Fight Deals That Delay Generic Drugs - By Ana B. Ibarra 7.31.2019

 

Blumenthal Provides Common-Sense Solution to Drug Pricing Crisis - By Matthew Lane 7.30.2019

 

Sanders and Cummings, Citing 'Polite F-u Letters,' Urge Feds to Step Up Probes of Generic Makers - By Ed Silverman 6.13.2019

 

Michael Bennet, Cory Gardner Fight to Bring Down Drug Prices - By David O. Williams 5.20.2019

 

Collusion Over Drug Prices: Will Generic Manufacturers Pay? - By Robert Field and Stacie Dusetzina 5.20.2019

 

Drugmakers Allegedly Infalte Prices Over 1,000% and 44 States Are Now Suing - By CNBC 5.11.2019

 

Consumer Groups Submit Letter in Support of CREATES Act - By Michael DeLong 5.7.2019

 

Drug Industry Patents Go Under Senate Judiciary Committee's Microscope - By Rachel Bluth 5.7.2019

 

House to Vote On Bills to Update FDA's Purple and Orange Book - By Zachary Brennan 5.6.2019 

Gottlieb: Insurers Must Be Willing to Adopt Biosimilars - By Robert King 3.29.2019

 

House Energy and Commerce Committee Addresses Seven Bills to Improve Generic Competition - By Zachary Brennan 3.13.2019

 

Pharmaceutical Companies Face Grilling in Senate Over High Drug Prices - By Alison Kodjak 2.26.2019

 

FDA Approves More Generic Drugs, But Competition Still Lags - 2.25.2019

Generic Drug Approvals Surge, But Hundreds Still Aren't For Sale - By Sydney Lupkin and Jay Hancock 2.7.2019

Investigation of Generic 'Cartel' Expands to 300 Drugs - By Christopher Rowland 12.10.2018

 

Prescription Drug Prices: A Bitter Pill for the Midterm Elections - By Richard Eisenberg 10.31.2018

 

A Humira Prescription Costs $38,000 A Year Because Our Patent System Is Being Abused - By Priti Krishtel 10.28.2018

 

Abuse of U.S. Patent System Drive High Drug Prices - By Tahrir Amin 10.27.2018

 

FDA Approving Generic Drugs At Record Pace, Report Finds - By Alia Paavola 10.23.2018

 

Maryland Asks Supreme Court to Uphold Law Against Generic Drug Price-Gouging - By Kelly Gooch 10.22.18

 

Patents for Restasis Are Invalidated, Opening Door to Generics - By Katie Thomas 10.16.17

 

Senator McCaskill Drafts Bill in Response to Allergan Patent Maneuver - By Michael Erman 10.5.17

 

Allergan Responds to Mounting Criticism of Mohawk Patent Deal - By Meg Tirrell 10.3.17

 

Expanded Access: FDA Describes Efforts to Ease Application Process - By Scott Gottlieb 10.3.17

 

Judge: Maryland Can Act Against Drug Price Gouging, For Now - By Brian Witte 9.29.17

 

Why Are Drug Prices So High? We're Curious, Too - By Katie Thomas and Charles Ornstein 9.17.17 

A Billion Here, A Billion There: Selectively Disclosing Actual Generic Drug Prices Would Save Real Money - By Steven Lieberman, Margaret Darling, and Paul B. Ginsburg 9.12.17

 

FDA Is Advancing the Goals of the Orphan Drug Act - By Scott Gottlieb 9.12.17

 

Don't Let Pharma Take Down a New Maryland Price Gouging Law - By Jeremy A. Greene 9.8.17

 

Misguided Regulation Helped Create the Drug Price Crisis - By David Balto 9.6.17

 

FDA Chief Says Drug Makers Are Gaming the System to Slow Generic Competition; Vows Action - By Jayne O'Donnell 8.15.17

 

Congress Passes Bill to Fund FDA Drug, Medical Device Reviews - By Anna Edney 8.3.17

 

Gottlieb: FDA to Issue New Policies to Streamline Generic Reviews in 2017 - By Michael Mezher 7.18.17

 

FDA Says It Will Prioritize Generic Drugs to Help Control Prices - By the Associated Press 6.27.17

 

Maine Senate Gives Initial Approval to Bill Aimed at Lowering Prescription Prices - By Eric Russell 6.22.17 

 

Trump's New Policy to Tackle Sky-High Drug Prices Makes Sense - Sort Of - By Julia Belluz 6.21.17

 

FDA Working to Lift Barriers to Generic Drug Competition - By Scott Gottlieb 6.21.17

 

Would Price Transparency for Generic Drugs Lower Costs for Payers and Patients? - By Steven Lieberman and Paul Ginsburg 6.14.17

 

Trump's FDA Stirs a Generic-Drug Storm - By Max Nisen 6.9.17

 

'Product Hopping' Drives Up Drug Prices, But You can Still Save on Your Meds - By Ginger Skinner 6.2.17 

 

Congress Mulls Major Drug Pricing Proposals - Managed Care 5.30.17

 

How to Stop Drug Price Gouging By Tim Wu - New York Times 4.20.17

 

Biosimilars Are as Good as Brand-Name Drugs, New Study Finds​ By Steve Mitchell - Consumer Reports 8.8.16

Makers of Humira and Enbrel Using New Drug Patents to Delay Generic Versions By Andrew Pollack - The New York Times 7.15.16

Stop Pharma Hopping Mischief By David Balto - Law360 7.12.16

Brother may I? Congress must reform senseless drug regulation By David Balto -

The Hill 6.21.16

Endo sued over pay-for-delay deals in first-of-its-kind FTC challenge By Lisa Schenker - Modern Healthcare 3.31.16

Can the Government Stop the Next Martin Shkreli? By Jeremy A. Greene - Slate 3.22.16

'Pay-for-delay' deals protecting branded drugs are falling By Lisa Schenker - Modern Healthcare 1.14.16

A Surprising Way Big Pharma Keeps Drug Prices High By Steve Mitchell - Consumer Reports 10.13.15

Teva will pay $1.2 billion in FTC pay-for-delay settlement By Lisa Schenker - Modern Healthcare ​5.28.15

Appeals court orders Actavis to continue selling Alzheimer's drug By Lisa Schenker - Modern Healthcare 5.22.15

Removing Obstacles to Generic Drug Competition

A Critical Priority for Health Care Reform

By David Balto

For Center for American Progress

June 2009

Thirty years ago former Supreme Court Chief Justice Warren Burger explained that “Congress designed the Sherman Antitrust Act of 1890 as a ‘consumer welfare prescription,’” to help average Americans benefit from the fruits of market-based competition by limiting monopolies and cartels in the U.S. economy. U.S. antitrust laws such as the Sherman Act and subsequent laws indeed assure that competition is the lodestar of the marketplace and that consumers receive the full benefits of competition in lower prices and better services.

One of the sectors in which antitrust enforcement is crucial is in the pharmaceutical industry, which accounts for an increasingly large part of our overall healthcare expenditures. Fortunately, during both the Clinton and Bush administrations, both state and federal antitrust enforcers, bolstered by private actions, began to approach pharmaceutical competition concerns in a disciplined fashion, bringing cases that clarified the law and stopped conduct that denied consumers the benefits of lower priced generic drugs. Despite these increased efforts, however, there are numerous forms of anticompetitive conduct that continue in pharmaceutical markets because of the ability of companies to manipulate the regulatory process and some misguided decisions of the courts.

Stopping these types of anticompetitive conduct could not be a greater priority for the Obama administration’s antitrust enforcers. With more than $60 billion in drugs scheduled to go “off patent” during the remainder of the President’s first term, stopping anticompetitive conduct in the pharmaceutical industry is crucial to controlling health care costs. If antitrust is a “consumer welfare prescription,” then our health care system is certainly in need of a prescription for an added dose of enforcement in pharmaceutical markets.

This paper will begin by discussing the importance of ensuring competition from generic pharmaceutical companies once patents expire on drugs developed by brand-name pharmaceutical companies. It then describes several industry factors that make pharmaceuti- cal markets different from other markets—differences that enhance the opportunity for abuses of market power and anticompetitive conduct more generally.

This paper then examines four types of anticompetitive conduct that may delay the emergence of generic drugs:

  • Exclusion payments, or payments made by brand-name manufacturers to generic companies in settlements of patent litigation, which may delay the entry of the generic drug

  • Product hopping, or extending the period of patent protection by obtaining patents on trivial modifications of a drug and switching the market to the new protected version

  • Authorized generics, or drugs manufactured by brand-name companies sold under generic labels, which are designed to reduce incentives for generic companies to challenge patents

  • Misuse of the regulatory system through sham filings with the Patent Office, the Food and Drug Administration, and in courts.

In each of these cases, the paper discusses possible remedial legislative and enforcement approaches. Specifically:

  • Congress should pass legislation expressly prohibiting exclusion payments in patent settlements

  • The Federal Trade Commission should investigate and bring cases to challenge product hopping where it has anticompetitive effects

  • Congress should enact a ban on authorized generics and the Federal Trade Commission should bring cases to prevent their use

  • The Federal Trade Commission should investigate and challenge the use of sham regulatory filings, such as citizen petitions and other efforts to subvert the regulatory process.

Read the full paper here.

Spotlight on: The CREATES Act

Spotlight on: The CREATES Act

Statement of Senator Patrick Leahy Hearing on “The CREATES Act: Ending Regulatory Abuse, Protecting Consumers, and Ensuring Drug Price Competition”

In recent months, the high cost of prescription drugs has been front and center in national news. Last year, American consumers learned of the unconscionable price-hike by Turing of their drug for HIV patients. New owners of that company increased the price of their medicine from $13.50 to $750 per pill overnight, an increase of 5000 percent. Think for a moment about the impact of a price hike like that on the family of a patient facing a life-threatening illness. Across the country, hard-working Americans feel like the system is rigged against them by corporations that are looking to make a profit at any price. With examples like Turing, it is no wonder they feel that way.

The legislation I have introduced with Senators Grassley, Klobuchar and Lee addresses anticompetitive conduct that helped Turing drive up its prices. Our CREATES Act targets predatory delay tactics that some brand-name drug manufacturers are using to block competition from more affordable generic drugs.

The first delay tactic addressed by the CREATES Act involves the withholding of drug samples that generic manufacturers need to gain regulatory approval. Federal law requires generic competitors to prove that their low-cost alternative is equally safe and effective as the brand-name drug with which they wish to compete. Unfortunately, some brand-name companies are refusing to provide samples of their product to generic companies for them to make the necessary comparison. This simple delay tactic uses regulatory safeguards as a weapon to block competition. The FDA has reported receiving more than 100 inquiries from generic product developers who were unable to access samples of a brand-name drug to compare their generic product.

The second delay tactic addressed by the CREATES Act involves the development of shared safety protocols. For some high-risk drugs, federal law requires a generic drug manufacturer to join the brand-name drug manufacturer in a single, shared safety protocol for distribution of the drug. Despite this requirement, some brand-name companies are refusing to negotiate a shared safety protocol with potential generic competitors, again undermining those competitors’ ability to gain FDA approval for their generic version of the drug.

The practices addressed by the CREATES Act thwart competition and deny consumers the benefit of lower drug prices. They also undermine the careful balance created in the Hatch-Waxman Act and the more recent Biologics Price Competition and Innovation Act, which are designed to reward and incentivize innovation while ensuring that consumers ultimately benefit, after a certain time, from the entry of generic or biosimilar versions of a drug.

Pharmaceutical companies should be compensated for their important work developing life-saving treatments. But when companies engage in predatory practices at the expense of consumers, we must act. Our bill creates a sensible, efficient way for generic drug manufacturers to address these delays without jeopardizing patient safety or creating protracted litigation in the courts.

I share the concerns of Vermonters and Americans across the country that many prescription drugs are simply too expensive for consumers. When brand companies can drive up the price of drugs by using predatory practices, patients suffer. Illnesses get worse. Families, government programs, and other payers in the healthcare system ultimately bear those added, unnecessary costs.

The CREATES Act is supported by consumer groups, physicians, pharmacists and hospitals who all see firsthand the impact of the high costs of prescription drugs. I thank them for working with us on this legislation, as well as the antitrust experts and medical professionals who helped ensure it is an effective, narrowly-tailored bill.

Unfortunately, this legislation is not a silver bullet to address all of the complex problems driving the high costs of medications. In addition to the delayed entry of generic drugs, I am troubled by the rising cost of treatments for opioid overdoses, which remain expensive for local law enforcement even though there are generic competitors. In Vermont, many patients are grappling with the extremely high cost of a new drug for Hepatitis C that will likely have years of market exclusivity before generic alternatives can be made. The Judiciary Committee has jurisdiction over intellectual property policy, and we recognize the importance of ensuring that pharmaceutical companies can recoup the expensive costs of their research so they can continue to develop new treatments. We also recognize that other participants in the supply chain and other factors contribute to the high cost of prescription drugs. But patients are struggling. We must find thoughtful solutions to address the impossibly high prices of some prescription drugs.

With the CREATES Act, the bipartisan leaders of the Judiciary Committee and its Subcommittee on Antitrust, Competition Policy and Consumer Rights are contributing one piece of the puzzle by addressing anticompetitive behavior that delays the creation of affordable generic drugs. I hope other members both on and off this Committee will work with us on thoughtful, bipartisan solutions to address the high costs of prescription drugs.

I thank Senators Grassley, Klobuchar and Lee for joining me in this effort and for holding this hearing on our bill. I look forward to the witnesses’ testimony.

Statement of Senator Patrick Leahy Hearing on “The CREATES Act: Ending Regulatory Abuse, Protecting Consumers, and Ensuring Drug Price Competition”

Mylan Pharmaceuticals Inc. v. Warner Chilcott PLC Ltd. (United States Court of Appeals for the Third Circuit). Amicus brief on behalf of AARP, Consumers Union, DC 37, Consumer Action, Consumer Federation of America, Families USA, Sergeants Benevolent Association, National Health Law Program, Center for Medicare Advocacy, and US PIRG urging reversal of the district court's ruling that a product hopping scheme could not be anticompetitive under the antitrust laws.

In Re: Loestrin 24 Fe Antitrust Litigation (United States Court of Appeals for the First Circuit). Amicus brief on behalf of consumer groups AARP, Consumer Action, Consumers Union, Families USA, Public Citizen, and USPIRG in support of reversal of the district court's ruling that a reverse payment scheme to delay the generic entry of an oral contraceptive is not anticompetitive.

State of New York v. Actavis, PLC, and Forest Laboratories, LLC. (United States Court of Appeals for the Second Circuit). Amicus brief on behalf of 8 consumer groups and payors in support of New York's challenge of a product hopping scheme that could cost Alzheimer's patients and the healthcare system over $1 billion.

State of New York v. Actavis, PLC, and Forest Laboratories, LLC. (United States Court of Appeals for the Second Circuit). Amicus brief on behalf of the American Geriatrics Society and the Medical Society of the State of New York in support of New York's challenge of a product hopping scheme that could cost Alzheimer's patients and the healthcare system over $1 billion.

In Re Lamictal Direct Purchaser Antitrust Litigation (United States Court of Appeals for the Third Circuit).  Amicus brief on behalf of AARP, Legislative Association on Prescription Drug Prices, and the United States Public Interest Research Group in support of appellant that non-money, pay-for-delay agreements coupled with non-authorized generic settlements are anticompetitive and harmful to consumers. 

FTC v. Watson (United States Supreme Court). Amicus brief on behalf of AARP, the American Medical Association, the National Legislative Association on Prescription Drug Prices and US PIRG in support of FTC's position that pay-for-delay payments are anticompetitive and harmful to consumers.

Caraco Pharmaceutical Laboratories, et al. v. Novo Nordisk (United States Supreme Court). Amicus brief on behalf of AARP and U.S. PIRG in support of Petitioner Caraco's brief to combat abusive patent use filings and Orange Book manipulation.

Caraco Pharmacuetical Laboratories, et al. v. Novo Nordisk (United States Supreme Court).  Amicus brief on behalf of AARP and US PIRG in support of Caraco Pharmaceutical Laboratories, et al as the Federal Circuit's opinion misreads the law, and abrogates the legislative intent.

Louisiana Wholesale Drug Co., et al v. Bayer, et al (Cipro) (United States Supreme Court).  Amici Curiae brief on behalf of the Consumer Federation of America, Prescription Access Litigation LLP, The National Legislative Association on Prescription Drugs and US PIRG in support of the Petitioner, urging the Court to grant certiorari to reverse the court below, to give effect to the Hatch-Waxman Act, and to save consumers billions of dollars from anti-competitive settlements. 

Novo Nordisk v. Caraco Pharmaceutical Laboratories, et al. (United States Court of Appeals for the Federal Circuit).  Amicus brief on behalf of The Consumers Federation of America in support of Caraco Pharmaceutical Labratories, et al petition for rehearing En Banc.