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Congress should pass strong reforms to fix our broken drug safety system and ensure that patients and doctors have full information on dangerous drug side effects.

A Record Year for the Pharmaceutical Lobby in '07
Washington's largest lobby, the pharmaceutical industry, racked up another banner year on Capitol Hill in 2007, backed by a record $168 million lobbying effort, according to a Center for Public Integrity analysis of federal lobbying data.

Consumers Union petitions the FDA on drug safety
All too often, drug advertisements fail to present the benefits and risks of using prescription drugs in an accurate and balanced way.

Avandia and the Commerical Impact of FDA's Credibilty Gap
GlaxoSmithKline’s diabetes drug Avandia survived a perilous FDA advisory committee review. The real question is whether the industry can survive the damage to FDA’s credibility.

Drug safety bill moves to Conference Committee; send strong bill to the President!
Both houses of Congress have just passed historic drug safety reform legislation (S. 1082, HR 2900) that would allow the FDA to enforce labeling changes, complete safety studies, and more quickly take action to protect the public if a drug proves unsafe. The bill would also give the FDA the authority to impose meaningful fines on drug companies that fail to comply with safety measures.

Read the text of HR 2900, the House drug safety bill
Read the text of key provisinos of HR 2900, the House version of the drug safety bill now on its way to the floor for a vote. Your representative will get a chance to vote on this bill in July. Help us make sure he or she votes YES! The full bill can be viewed at www.thomas.gov by searching for the bill number HR 2900.

HR 2900 continued
Section 603 through Section 901 of HR 2900.

HR 2900 continued to end
Section 901 to the end, key sections of HR 2900. To view the full bill, visit www.thomas.gov and search for bill number HR 2900.

Strong drug safety legislation goes to US House floor for a vote
Lawmakers in the US House will soon vote on a strong drug safety bill that allows the FDA to enforce labeling changes, complete safety studies, and more quickly take action to protect the public if a drug proves unsafe. The bill would also give the FDA the authority to impose meaningful fines on drug companies that fail to comply with safety measures.

Testimony of Jim Guest President, Consumers Union, before the House
On PDUFA, Risk Evaluation & Mitigation Strategies, Clinical Trials, and Advisory Committee Conflicts. Click here to read the summary.

Representative Markey questions drug industry lobbyist
During a hearing of the House Energy and Commerce Subcommittee on Health, Representative Edward J. Markey (D-MA) questioned PhRMA representative, Dr. Caroline Lowe, senior vice president of scientific and regulatory affairs, about PhRMA’s opposition to Markey’s proposal for a stronger FDA drug safety system.

How did your Senator vote on drug safety?
The Senate heard drug safety legislation and amendments over several days, with record votes on reimportation, conflict of interest, stronger post-market review and much more. Take a look at your Senator's voting record.

Putting patient safety first & fixing our drug safety system
Recent controversies surrounding the safety of highly advertised, blockbuster drugs have eroded Americans’ trust in our drug safety system.

Battle for drug safety moves to House floor
A March 2007 Consumer Reports national poll found that more than 60 percent of Americans agree that the Food and Drug Administration and Congress have failed to adequately protect them from harmful prescription drugs.

Text of S. 1082 Senate Drug Safety Bill
S.1082 Food and Drug Administration Revitalization Act (Engrossed as Agreed to or Passed by Senate)

Further Actions Needed to Improve FDA's Postmarket Decision-making Process
GAO found that FDA lacked clear and effective processes for making decisions about, and providing management oversight of, postmarket drug safety issues.

Drug and health products industries invest $182 million to influence legislation
Manufacturers of pharmaceuticals, medical devices and other health products spent nearly $182 million on federal lobbying from January 2005 through June 2006, a Center for Public Integrity study of disclosure records shows.

Grassley says FDA problems need sunshine, calls on Commissioner to reverse chill factor
Sen. Chuck Grassley said that statements by the Commissioner of the FDA discourage agency employees and scientists from speaking up about problems with the way the FDA monitors drug safety.

FDA witholds important safety information from its own advisory panel, Senator says
Sen. Chuck Grassley said the Food and Drug Administration intentionally withheld key information from its own advisory panel on the drug Ketek in January 2003 about the integrity of a pivotal clinical trial used to support the safety of the drug and dismissed concerns expressed by staff-level officials before the advisory panel meeting.

Improvements needed in FDA's oversight of direct-to-consumer advertising, new study finds
The government's investigative arm finds that drug company spending on DTC advertising—such as that on television and in magazines—of prescription drugs increased twice as fast from 1997 through 2005 as spending on promotion to physicians or on research and development. The agency also says that DTC advertising has contributed to increases in drug spending by prompting consumers to request the advertised drugs from their physicians.

Drug Reps per Physician
According to research from Health Strategies Group, “[t]he average primary care physician interacts with 28 sales representatives each week; the average specialist interacts with 14.”

When Clinical Trials Are Compromised: A Perspective from a Patient Advocate
Twelve years ago, a friend from my breast cancer support group went to court because her insurance company had refused coverage for a bone marrow transplant. Her first transplant had failed and her cancer was progressing again. The insurance company refused coverage for the second transplant on the basis that it was an experimental treatment. The judge, a cancer survivor himself, was clearly moved by her appeal, and my friend got her transplant. Six months later, she was dead—not from her metastatic breast cancer, but from treatment-induced damage to her bone marrow. Read more here...

Health industry practices that create conflicts of interest (PDF)
The current influence of market incentives in the United States is posing extraordinary challenges to the principles of medical professionalism.

Grassley, Baucus seek more details of drug company grant money (PDF)
The senators are concerned that sales and marketing personnel – rather than medical professionals – continue to award drug company money to medical specialty groups and patient advocacy groups to promote product use, especially off-label use.

Clinical trial registry analysis shows company secrecy continues
Some drug companies that have started to place information about their clinical trials in the nation's public registry still do not place enough meaningful information there, according to a new study by the New England Journal of Medicine.

New England Journal of Medicine chastises Merck for hiding data
Recent findings regarding inaccuracies in data in the report of the VIGOR (Vioxx Gastrointestinal Outcomes Research) study by Bombardier et al.1 that raise concern about certain conclusions in the article.

Drug companies manipulate research findings
Jennifer Washburn (author of University.Inc: The Corporate Corruption of American Higher Education) publishes original documents in the online magazine Slate supporting contentions that Proctor and Gamble ghost wrote research findings for its researchers and refused to allow researchers full access to the underlying data.

Female and Elder Consumers and Payers Sue Pfizer Over Deceptive Marketing of Lipitor (R) (PR Newswire Sept. 28, 2005)
Plaintiffs Allege Promotional Scheme to Boost Sales of World's Best-Selling Drug by Misleading Women and Seniors About Link Between the Drug and Heart Disease

Maine first state in nation to require public clinical trials
Groundbreaking law will help improve drug safety for all Americans

Sen. Chuck Grassley’s take on the FDA’s drug safety program
Asks tough questions during Consumer Federation of America conference

Pass legislation to force disclosure of drug info (PDF)
How can drugs approved by the federal government and heavily advertised sometimes do more harm than good?

FDA official's testimony about drug safety
"Vioxx is a terrible tragedy and a profound regulatory failure. I would argue that the FDA, as currently configured, is incapable of protecting America against another Vioxx. We are virtually defenseless."

FDA’s proposed changes to drug safety program
Agency responds to concerns with Vioxx and anti-depressants

Settlement sets new standard for release of drug information
Attorney General Eliot Spitzer today announced an agreement that resolves charges that a leading pharmaceutical company concealed information about the safety and effectiveness of one of its drugs.

Minnesota: Information you should have before your next doctor visit
Consumer Reports Best Buy Drugs identifies the most effective, safest and affordable medicines based on the scientific evidence, not drug company hype. Take these materials to your doctor to discuss which medicines might be right for you, and whether you can save money.

PrescriptionForChange.org provides consumers with timely information about prescription drug issues and current efforts at the state and federal level to improve safety, effectiveness, and access to medicines. To find out more, click here.

Medicare Drug Plan
Advice and information on the new drug benefit, as well as how you can tell Congress to make the program easier, more affordable for seniors.

Consumer Reports Best Buy Drugs
Consumer Reports identifies the most effective, safest and affordable medicines based on the scientific evidence, not drug company hype. Take free reports to your doctor to discuss which medicines might be right for you, and whether you can save money.

Consumers Union's work to improve access to safe, affordable prescription drugs - testimony, reports and analyses

Congress should impose 3-year wait on drug ads
New ads should include 1-800 number and website to report adverse effects

FDA is an agency in dire need of major reform
CU testimony regarding the Drug, Device, and Cosmetic Safety provisions of the “FDA Globalization Act”

TV drug ads should tell how to report side effects
New Consumer Reports poll finds most Americans don't know they should tell the FDA

Sign petition to FDA: Give us a voice on drug ads
Petition asks FDA to put toll-free number, Web address on TV ads so consumers can report side effects

Over-the-counter cholesterol drug opposed
CU against Merck's proposal because high choleserol can't be self-diagnosed; drugs can have serious side effects

Drug safety law major victory for consumers
Ensures patients, doctors know more quickly about dangerous meds; holds industry's feet to the fire

Victory! Pro-consumer reforms in drug safety bill
Public clinical trial results, $400 million for improved safety monitoring and tougher fines on drug companies in final bill

Report: White House opposes drug safety section
Administration reportedly opposes House language on requiring public drug trial results database

Finish drug safety bill to get FDA moving on reforms
Patients, doctors would know sooner about risky drugs like Avandia if legislation gets finalized, sent to president

Victory: House passes drug safety bill!
CU urges conference committee to keep strong House safety provisions before sending final bill to President

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