The Hatch-Waxman Act and New Legislation to Close Its Loopholes
Drug Price Competition and Patent Term Restoration Act of 1984.
Status, Abstract and Summary from the Thomas database.
S.1225 - Greater Access to Affordable Pharmaceuticals Act (Introduced in Senate).
The Drug Price Competition and Patent Term Restoration Act of 1984,
usually refered to as the Hatch-Waxman Act, was designed to promote generics
while leaving in tact a financial incentive for research and development.
It allows generics to win FDA marketting approval by submitting bioequivelence
studies (as opposed to clinical data, which is costlier to compile). It
also grants a period of additional marketing exclusivity
to make up for the time a patented pipeline drug remains in development.
This extension cannot exceed five years, and it is in addition to the
20 years exclusivity granted by the issuance of a patent.
Another provision of the Hatch-Waxman grants a 30-month stay to drug
companies that file suit against generic manufactures that challenge their
patents. This has become controversial in recent years, as pharmaceutical
companies have used the provision to keep generics off the market by
protecting their drugs with extra patents of poor quality, filing lawsuits
to protect the patents even when the lawsuit will be lost,
but getting the extra market exclusivity anyway.
Last year, two bills sought to close loopholes in the law exploited by
companies to keep generics off the market. The first was S. 812,
introduced on May 1, 2002 by Senators. McCain and Schumer and passed
on July 31. The House version of the legislation, H.R. 1862,
was introduced by Sherrod Brown on May 16, but stalled in the
House. On October 21, President Bush announced his intention to
use regulatory authority to limit companies to one 30-month
extention, and to tighten rules on what patents can be
listed in the FDA's Orange Book.
This year, Senators Gregg, Schumer,
McCain and Kennedy have introduced similar legislation -S. 1225 - in the Senate.
Statements About and Studies of the Hatch-Waxman Act.
- September, 2002. IMS Health.
FDA Generic Approval — How Market Forces Are Pushing the Agency.
- July 30, 2002. Federal Trade Commission report.
Generic Drug Entry Prior to Patent Expiration. This report specifically
calls for two reforms to the Hatch-Waxman Act:
- Allowing only one 30-month stay on the entry of a generic drug during
pending patent-infringement litigation.
- Requiring brand-name companies and the first generic applicants to
provide copies of out-of-court settlements to the FTC and the Department
of Justice to ensure that competition is not compromised.
- July 30, 2002. FTC press release.
FTC Recommends Legislative Changes to Hatch-Waxman Act.
- May 30, 2002. PhRMA's Stats & Facts newsletter.
Hatch-Waxman Strikes Delicate Balance Between Innovator Intellectual
Property Protection and Quick Generic Entry Into Market.
Summary of Rep. Waxman's speech on the Hatch Waxman Act given November 29, 2001.
- May 24, 2001. Gary Buehler, Acting Director, Office of Generic Drugs,
Center for Drug Evaluation and Research, FDA.
the Senate Judiciary Committee.
- October 11, 2000. Federal trade Commission press release.
FTC to Study Generic Drug Competition.
The proposed study would examine whether the 30-month stay and
180-day marketing exclusivity provisions of the Hatch-Waxman Act
have encouraged generic competition or facilitated the use of
- July, 1998. Congressional Budget Office Report.
How Increased Competition from Generic Drugs Has Affected Prices and
Returns in the Pharmaceutical Industry.
- Gerald J. Mossinghoff. (Former preseident of PhRMA).
Article published online by Oblon, Spivak, McClelland, Maier & Neustadt.
Overview of the Hatch-Waxman Act and Its Impact on the Drug Development Process.
- S.1225 - The Greater Access to Affordable Pharmaceuticals Act
Text of the bill in a PDF format.
- June 19, 2003. Sen. Gregg's office.
Gregg Includes Measure to Make More Prescription Drugs
Available in Medicare Reform Bill.
- June 19, 2003. Sen. Schumer's office.
Schumer Generic Drug Legislation Passes Full Senate.
- June 19, 2003.
Excerpts from Floor Statement of Sen. John McCain.
- June 19, 2003. Generic Pharmaceutical Association.
Consumers Are the Victors in Sweeping Senate Approval of
Affordable Pharmaceuticals Measure, GPhA Says.
- June 17, 2003. PhRMA.
Patent Incentives for Discovery of New Medicines Must Be Maintained, PhRMA Tells Lawmakers.
- June 11, 2003. Sen. Gregg's office.
Breakthrough, Bipartisan Legislation to Make More Prescription Drugs
Affordable, Available Gets Boost -
Legislation is approved by Senate HELP Committee, under Sen. Gregg’s leadership.
- June 11, 2003. Sen. McCain's office.
McCain Presses for Senate Passage of Generic Drug Bill.
- June 11, 2003. Sen. Kennedy's office.
Statement of Senator Edward M. Kennedy on the Help Committee Markup of
"The Greater Access to Affordable Pharmaceuticals Act.”
- June 5, 2003. Sen. Gregg's office.
Gregg Secures Breakthrough Bipartisan Agreement: Will Create More
Access to More Affordable Prescription Drugs.
- June 5, 2003. Sen. Schumer's office.
Gregg, Schumer, McCain, Kennedy Reach Agreement on Groundbreaking Generic Drug Plan.
Contains a link to a
table comparing the Hatch-Waxman act to the Gregg-Schumer plan.
- June 5, 2003. Generic Pharmaceutical Association.
GPhA Praises Bipartisan Senate Compromise To Improve Consumer
Access to Affordable Prescription Drugs.
- June 5, 2003. The Coalition for a Competitive Pharmaceutical Market.
CCPM Applauds Bipartisan Senate Proposal to Increase Access to Generic Drugs;
Calls for Congress to Take Action to Reduce Rx Costs.
- News Stories
- June 20, 2003. Associated Press.
Senate Attaches Generic Drug Package to Medicare Bill.
- June 20, 2003. Amy Goldstein and Helen Dewar for the Washington Post.
Senate Approves Generic Drug Measure: Bill Would Make It Harder for
Companies to Keep Substitutes Off the Market.
- June 19, 2003. Joanne Kenen for Reuters.
US Senate to add generic drug bill to Medicare plan.
- June 20, 2003. Anne Q. Hoy for Newsday.
Senate OKs Generic Drug Step: Patent limits on brand-names
would speed such medication.
- June 19, 2003. Associated Press.
Senate Votes for Fast Access to Drugs.
- June 19, 2003. Bloomberg.
Senate Adds Generic-Drug Measure to Medicare Overhaul.
- June 17, 2003. Atlanta Journal Constitution editorial.
Drug bill deserves Congress' OK.
- June 12, 2003. Associated Press.
Senate panel OK's bill to speed generic drugs to the market.
- June 10, 2003. Associated Press.
Schumer urges support of generic drugs bill.
- June 5, 2003. Jim Abrams for the Associated Press.
Senators announce agreement on plan to improve access to generic drugs.
- June 4, 2003. Bloomberg.
U.S. Senators Agree on Bill to Speed Generic Drugs to Market.
- H.R. 2474 - The Pharmaceutical Market Access Act
- FDA Revised Rules to Reform the Hatch-Waxman Act and Speed Access to Generics
President Bush's Announcement on Limiting 30-Month Extentions
- Government Documents
- NGO Documents
- News stories
- January 3, 2003. InsideHealthPolicy.com.
GPhA Opposes FDA Plan For One 30-Month Stay Per ANDA - Group
Will Continue to Push for Legislation.
- December 27, 2002. Blooomberg News.
Generic drug firms hit plan.
- December 26, 2002. Chris Adams for the Wall Street Journal.
Drug Makers Blast Bush Bid To Speed Generics to Market.
- October 23, 2002. Op-ed by Scott Gottlieb for the Wall Street Journal.
- October 22, 2002. Knight-Ridder.
Bush Backs Shortened Patent Periods to Make Generic Drugs More Accessible.
- October 22, 2002. Scott Lindlaw for the Associated Press.
Bush Aims to Block Generic-Drug Lawsuits.
- October 22, 2002. Amy Goldstein for the Washingon Post.
Bush Plan to Increase Generic Drugs Draws Flak.
- October 22, 2002. Washington Post editorial.
Mr. Bush Changes Sides.
- October 22, 2002. Robert Pear for the New York Times.
Bush plan would speed OK of generic drugs.
- October 22, 2002. New York Times editorial.
Ending a Drug Patent Scam.
- October 22, 2002. Ken Fireman for Newsday.
New Plan For Generic Drugs: Democrats criticize timing.
- October 22, 2002. Vincent Morris for the New York Post.
Bush Bares Rx for Prescriptions.
- October 22, 2002. David Teather for the Guardian.
Bush Takes on Drug Firms.
- October 21, 2002. Scott Lindlaw for the Associated Press.
Bush Moves on Generic Drug Access.
- October 21, 2002. Randall Mikkelsen for Reuters.
Bush Seeks to Speed Low-Cost Generic Drug Access.
- October 21, 2002. Amy Goldstein for the Washington Post.
Bush Announces New Rules on Generic Drugs.
- October 21, 2002. Chris Adams for the Wall Street Journal.
FDA to Speed Up Flow of Generics to Marketplace.
- October 21, 2002. CNN.
Bush pushes for quicker access to generic drugs.
- October 21, 2002. Christopher Bowe and Victoria Griffith
for the Financial Times.
Proposal on Patents Set to Hit Revenues.
- October 20, 2002 Elisabeth Bummiller for the New York Times.
Plan to Seek Faster Release of Generics.
H.R.1862/S.812 - Greater Access to Affordable Pharmaceuticals Act
- October 9, 2002. Timothy Muris, Chairman of the Federal Trade
Prepared Statement before the House Committee on Energy and Commerce,
Subcommittee on Health.
- October 9, 2002. Public Citizen Press Release.
Consumer Group Critical of House for Failing to Take Up Legislation
Easing Access to Lower-Priced Generic Drugs.
- October 9, 2002. PhRMA press release.
American Patients Benefit From Current Patent Law.
- October 9, 2002. Note to IP-Health email list from Mike Palmedo on
Political contributions from pharmaceutical industry to House
subcommittee that debated the reforms.
- July 31, 2002. Sen. Schumer's press release.
Senate Passes Groundbreaking Schumer-McCain Generic Drug Bill.
- July 31, 2002. Generic Pharmaceuticals Association press release:
GPhA Hails Passage of S. 812 as Major Consumer Victory.
- July 31, 2002. PhMRA press release.
Statement by Alan F. Holmer, President of the Pharmaceutical Research
and Manufacturers of America (PhRMA), on the Senate’s failure to pass
drug coverage for seniors and the disabled.
- July 16, 2002. Public Citizen press release.
Greater Access to Affordable Pharmaceuticals (GAAP) Act Fact Sheet.
- July 16, 2002. Janell Mayo Duncan, Legislative Counsel for Consumers Union.
Open Letter to Senate in Support of S.812.
- June 21, 2002. Press release from Senator John McCain.
McCain Urges Senate to Pass Generic Drug Bill Quickly to Make
Prescription Drugs More Affordable.
- May 8, 2002.
Statement of Sen. McCain to the Senate Committee on Health, Education,
Labor and Pensions.
- May 7, 2002. PhRMA press release.
Physicians Strongly Oppose Key Provision of McCain-Schumer Bill.
- May 1, 2001. Press release from Senator John McCain.
McCain, Schumer Unveil Initiative to Save Consumers $71 Billion on Prescription
- May 1, 2002. Press release from the Generic Pharmaceutical Association.
GPhA Welcomes Introduction of McCain-Schumer GAAP Act.
- October 11, 2001. FTC Press Release.
FTC to Study Generic Drug Competition. Annoucement of a proposed study to be
conducted by the FTC: "The proposed study would examine whether the 30-month stay and
180-day marketing exclusivity provisions of the Hatch-Waxman Act have encouraged
generic competition or facilitated the use of anticompetitive strategies."
- Business for Affordable Medicine.
This is a coalition of companies, state governments and labor unions. The
groups stated mission is "to improve employee access to affordable health
care through reform of the federal Hatch-Waxman Act."
- April 29, 2003. Debra Z. Anderson for the Pittsburg Post-Gazette.
The Private Sector: Delaying Cheap Pills.
- October 9, 2002. Julie Rovner for Reuters.
House Subcommittee Debates Generic Drug Bill.
- October 8, 2002. John Dorschner for the Miami Herald.
Generic drug delays decried.
- October 4, 2002. Bill Walsh for the Newhouse News Service
Generic Drug Reform Bill Stalls in House.
- October 3, 2002. Newsday editorial.
Give Consumers a Break; Pass Schumer Drug Bill.
- September 16, 2002. Washington Post editorial.
Big Drug Makers' Tactics.
- July 31, 2002. Reuters.
Senate Eases Generic Drug Rules.
- July 31, 2002. Editorial in the Washington Post.
Drugs and Your Wallet.
- July 30, 2002. Gardiner Harris and Laurie McGinldy for the Wall Street Journal.
FTC Says Drug Firms Misuse Loopholes to Delay Generics.
- July 30, 2002. Robert Pear for the New York Times.
Patent Law Change Urged to Speed Generic Drugs.
- July 30, 2002. Editorial in the USA Today.
Drugmakers push to protect profits as costs rise.
- July 29, 2002. Laurie McGinley and Chris Adams for the Wall Street Journal.
Makers of Generic Drugs Find Potent Formula: Friends on Hill.
- May 29, 2002. Laurie McGinley for the Wall Street Journal.
Survey of FDA Approvals Questions Extensions for Patents, Fuels Feud.
- May 23, 2002. Michael Lewis for the National Post.
GSK tries to stop Apotex generic drug.
- May 21, 2002. Editorial in the Hartford Courant.
Encourage Generic Drug Use.
- May 9, 2002. Julie Rovner for Reuters.
US Federal Drug Law Authors Split on Need for Overhaul.