• Home
  • Latest
  • Fortune 500
  • Finance
  • Tech
  • Leadership
  • Lifestyle
  • Rankings
  • Multimedia

Trendingnow

1

Mark Cuban says he has the solution to growing income inequality, and it's to reward every employee—from CEO to janitor—with company stock

2

‘I want to die broke’: Billionaire philanthropist Denny Sanford dies after giving away $4 billion

3

'Dr. Doom' Nouriel Roubini says we're headed for universal basic income or 'some form of socialism' as AI revolutionizes work—He calls that optimistic

1

Mark Cuban says he has the solution to growing income inequality, and it's to reward every employee—from CEO to janitor—with company stock

2

‘I want to die broke’: Billionaire philanthropist Denny Sanford dies after giving away $4 billion

3

'Dr. Doom' Nouriel Roubini says we're headed for universal basic income or 'some form of socialism' as AI revolutionizes work—He calls that optimistic
Health

Lawmakers Want to Keep Big Pharma From Blocking Generic Drugs

By
Reuters
Reuters
Down Arrow Button Icon
By
Reuters
Reuters
Down Arrow Button Icon
June 15, 2016, 11:14 AM ET
Photograph by Bloomberg via Getty Images
Add Fortune on Google for similar content.

Four U.S. senators – two Democrats and two Republicans – introduced a bill on Tuesday aimed at preventing big pharmaceutical companies from using safety rules to prevent generic drugs from coming to market.

Senators Charles Grassley, chair of the Judiciary Committee, and Patrick Leahy, the top Democrat, are sponsors of the bill along with Senators Mike Lee and Amy Klobuchar, the chair of the antitrust subcommittee and top Democrat, respectively.

The Food and Drug Administration, which ensures the safety of the country’s food and drug supply, has a risk evaluation and mitigation strategy program, called REMS, which is designed to ensure that the riskiest drugs are dispensed safely.

But there have been complaints that the program has been misused by brand-name drug companies to prevent generic manufacturers from getting the drug samples needed to market cheaper versions. Generic companies also complain their drugs are not allowed to share a safety protocol, making it difficult to come to market.

 

The bill would allow a generic manufacturer who faces either of these situations to file a lawsuit to force access to a sample or force negotiations for a safety protocol.

“Balancing the cost of developing lifesaving medications with the need to make available affordable prescription drugs to consumers has always been a difficult task. It’s a consistent topic at my town meetings,” Grassley said in a statement.

“Unfortunately, we’re seeing some brand-name drug companies engage in anti-competitive tactics that delay entry of lower cost generic drugs into the market. This bill takes important steps to ensure that our laws are not frustrated.”

There is a similar bill in the House of Representatives which addresses the same issue but uses a different strategy. For example, it requires the generic company seeking a REMS drug to get FDA authorization to obtain the sample.

In one of the REMS disputes which is public, Mylan Pharmaceuticals filed a lawsuit in 2014 against Celgene Corp , accusing it of using REMS to prevent generic copies of Thalomid and Revlimid to market.

The Senate Judiciary Committee’s antitrust panel will hold a hearing on its bill on June 21.

[fortune-brightcove videoid=4667531014001]

 

The Pharmaceutical Research and Manufacturers of America, or PhRMA, which counts major drugmakers among its members, said it had no immediate comment.

The Generic Pharmaceutical Association was pleased to see the bill introduced.

“It is worth noting and recognizing recent efforts by representatives in the branded industry to highlight the valuable role generic medicines play in driving healthcare system savings,” said Chip Davis, GPhA’s president. “Continued use of these anticompetitive practices by certain manufacturers drives the exact opposite outcome.”

About the Author
By Reuters
See full bioRight Arrow Button Icon
Add Fortune on Google for similar content.

Latest in Health

Finance
Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam
By Fortune Editors
October 20, 2025
Finance
Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam
By Fortune Editors
October 20, 2025
Finance
Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam
By Fortune Editors
October 20, 2025
Finance
Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam
By Fortune Editors
October 20, 2025
Finance
Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam
By Fortune Editors
October 20, 2025
Finance
Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam
By Fortune Editors
October 20, 2025

Most Popular

Finance
Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam
By Fortune Editors
October 20, 2025
Finance
Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam
By Fortune Editors
October 20, 2025
Finance
Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam
By Fortune Editors
October 20, 2025
Finance
Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam
By Fortune Editors
October 20, 2025
Finance
Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam
By Fortune Editors
October 20, 2025
Finance
Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam
By Fortune Editors
October 20, 2025
Fortune Secondary Logo
Rankings
  • 100 Best Companies
  • Fortune 500
  • Global 500
  • Fortune 500 Europe
  • Most Powerful Women
  • World's Most Admired Companies
  • See All Rankings
  • Lists Calendar
Sections
  • Finance
  • Fortune Crypto
  • Features
  • Leadership
  • Health
  • Commentary
  • Success
  • Retail
  • Mpw
  • Tech
  • Lifestyle
  • CEO Initiative
  • Asia
  • Politics
  • Conferences
  • Europe
  • Newsletters
  • Personal Finance
  • Environment
  • Magazine
  • Education
Customer Support
  • Frequently Asked Questions
  • Customer Service Portal
  • Privacy Policy
  • Terms Of Use
  • Single Issues For Purchase
  • International Print
Commercial Services
  • Advertising
  • Fortune Brand Studio
  • Fortune Analytics
  • Fortune Conferences
  • Business Development
  • Group Subscriptions
About Us
  • About Us
  • Press Center
  • Work At Fortune
  • Terms And Conditions
  • Site Map
  • About Us
  • Press Center
  • Work At Fortune
  • Terms And Conditions
  • Site Map
  • Facebook icon
  • Twitter icon
  • LinkedIn icon
  • Instagram icon
  • TikTok icon
  • YouTube icon

Latest in Health

The Best Fiber Supplements of 2026: Tested and Reviewed
HealthDietary Supplements
The Best Fiber Supplements of 2026: Tested and Reviewed
By Christina SnyderJuly 21, 2026
3 hours ago
A family crisis inspired Bill Ackman to spend $260 million to create a massive brain research institute in Manhattan
InnovationBill Ackman
A family crisis inspired Bill Ackman to spend $260 million to create a massive brain research institute in Manhattan
By Jeff John RobertsJuly 21, 2026
4 hours ago
traffic
HealthAutos
Rich countries have cut road deaths by more than 30% in 30 years—but about 90% of fatal crashes now happen in poorer nations
By Mike Stobbe and The Associated PressJuly 21, 2026
10 hours ago
Three women chop their way into the record books at Lumberjack World Championships
North AmericaWisconsin
Three women chop their way into the record books at Lumberjack World Championships
By The Associated Press and Ellen SchmidtJuly 20, 2026
1 day ago
Ferran Torres
SuccessWorld Cup
Spain’s Ferran Torres scored the winning goal in the World Cup—but just four years ago, he was in therapy and stuck in a ‘bottomless pit’
By Emma BurleighJuly 20, 2026
1 day ago
FDA walks back positive lab test while lettuce recall continues
HealthFood and drink
FDA walks back positive lab test while lettuce recall continues
By Bloomberg, Kristina Peterson, Jessica Nix and Daniela SirtoriJuly 20, 2026
1 day ago

Most Popular

Mark Cuban says he has the solution to growing income inequality, and it's to reward every employee—from CEO to janitor—with company stock
Success
Mark Cuban says he has the solution to growing income inequality, and it's to reward every employee—from CEO to janitor—with company stock
By Sasha RogelbergJuly 20, 2026
1 day ago
‘I want to die broke’: Billionaire philanthropist Denny Sanford dies after giving away $4 billion
Success
‘I want to die broke’: Billionaire philanthropist Denny Sanford dies after giving away $4 billion
By Sydney LakeJuly 20, 2026
1 day ago
'Dr. Doom' Nouriel Roubini says we're headed for universal basic income or 'some form of socialism' as AI revolutionizes work—He calls that optimistic
AI
'Dr. Doom' Nouriel Roubini says we're headed for universal basic income or 'some form of socialism' as AI revolutionizes work—He calls that optimistic
By Jason MaJuly 18, 2026
3 days ago
The Treasury is walking a tightrope on U.S. debt by relying so much on short-term rates that are at the mercy of a suddenly very hawkish Fed
Economy
The Treasury is walking a tightrope on U.S. debt by relying so much on short-term rates that are at the mercy of a suddenly very hawkish Fed
By Jason MaJuly 20, 2026
1 day ago
Current price of silver as of Monday, July 20, 2026
Personal Finance
Current price of silver as of Monday, July 20, 2026
By Joseph HostetlerJuly 20, 2026
2 days ago
Jamie Dimon won't put more of his own money into the long end of the bond market right now—thanks to the $39 trillion national debt
Economy
Jamie Dimon won't put more of his own money into the long end of the bond market right now—thanks to the $39 trillion national debt
By Eleanor PringleJuly 21, 2026
12 hours ago

© 2026 Fortune Media IP Limited. All Rights Reserved. Use of this site constitutes acceptance of our Terms of Use and Privacy Policy | CA Notice at Collection and Privacy Notice | Do Not Sell/Share My Personal Information
FORTUNE is a trademark of Fortune Media IP Limited, registered in the U.S. and other countries. FORTUNE may receive compensation for some links to products and services on this website. Offers may be subject to change without notice.