!! History Commons Alert, Exciting News

Context of 'June 26, 2006: Congressional Committee Investigation Finds Dramatic Reduction in FDA Enforcement Activity'

This is a scalable context timeline. It contains events related to the event June 26, 2006: Congressional Committee Investigation Finds Dramatic Reduction in FDA Enforcement Activity. You can narrow or broaden the context of this timeline by adjusting the zoom level. The lower the scale, the more relevant the items on average will be, while the higher the scale, the less relevant the items, on average, will be.

May 20, 1999: Vioxx Approved by FDA

The Food and Drug Administration approves Vioxx as a treatment for acute pain, dysmenorrhea, and osteoarthritis in adults, making the drug the second Cox-2 inhibitor available by prescription in the United States. [US Food and Drug Administration, 2005]

Entity Tags: US Food and Drug Administration

Timeline Tags: US Health Care

The Food and Drug Administration (FDA) announces that it will not permit pharmacies to sell the emergency contraception drug “Plan B” without a prescription. The drug is a “morning-after” birth-control drug that prevents fertilization and the implantation of the embryo. The agency explains to the manufacturer of the drug, Barr Pharmaceuticals, that the government is worried about the possibility that teenaged girls might not understand how to correctly use the drug without a doctor’s advice. The FDA’s decision is in direct contradiction of a federal advisory panel’s 23-4 decision to recommend approving the drug for over-the-counter sales, including to teenagers, without a doctor’s approval. The FDA’s staff recommended that the agency follow the panel’s recommendation. In 2007, author and reporter Charlie Savage will write, “Normally, agencies such as the FDA base their decisions on the information provided by their expert advisory panels—but, strangely, not this time.” A spokesman for the presidential campaign of John Kerry (D-MA) says: “By overruling a recommendation by an independent FDA review board, the White House is putting its own political interests ahead of sound medical policies that have broad support. This White House is more interested in appealing to its electoral base than it is in protecting women’s health.” James Trussell, director of the office of population research at Princeton University and a member of the advisory board, says, “The White House has now taken over the FDA.” Numerous women’s groups accuse the FDA’s political appointees of overruling the experts in order to please social conservatives who believe that the “Plan B” drug encourages promiscuity and is a form of abortion. In the following months, a lawsuit will be filed to have the FDA’s decision overturned (see January 21, 2005 and After). [New York Times, 3/7/2004; Savage, 2007, pp. 300-301]

Entity Tags: Charlie Savage, Barr Pharmaceuticals, Bush administration (43), James Trussell, John Kerry, Food and Drug Administration

Timeline Tags: US Health Care, Civil Liberties

The Congressional Committee on Government Reform ends a 15-month investigation aimed at assessing how the FDA is fulfilling its regulatory responsibilities. The committee’s report, based on thousands of pages of internal agency enforcement records, concludes that enforcement activity has dropped dramatically under the Bush administration. According to the review, the annual number of FDA warning letters fell 54 percent between 2000 and 2005, from 1,154 to 535, a 15-year low. Additionally, the number of seizures of mislabeled, defective, and dangerous products dropped by 44 percent. According to the investigation, there were at least 138 cases where the FDA ignored recommendations from agency field inspectors to take enforcement actions. [US Congress, 6/26/2006 pdf file; New York Times, 6/27/2006] In letters written to the committee, experts voiced concern that the FDA is becoming less vigilant in its oversight duties. Dr. Jerry Avorn of the Harvard Medical School, wrote that there is “a growing laxity in FDA’s surveillance and enforcement procedures,” a “dangerous decline in regulatory vigilance,” and an “obvious unwillingness to move forward even on claims from its own field offices.” Avorn describes the FDA as “an agency unwilling to exert its regulatory authority in defense of the public’s health.” [Avorn, 6/26/2006 pdf file] Dr. Michael Wilkes of the University of California, Davis, School of Medicine, says the FDA has “systematically ignored District Field Officers and regularly overridden their explicit and well documented concerns about drug safety and public health.” It “seems unable and unwilling to step in to protect the American public,” he adds. [Wilkes, 6/10/2006 pdf file] Another problem identified during the committee’s review of the documents concerns the agency’s record keeping. In response to questions from the committee, officials said the FDA lacks a centralized case tracking system and does not maintain a record of the enforcement recommendations made by its district offices. As a result, the investigation had to rely on the personal recollection of field office employees. [US Congress, 6/26/2006 pdf file]

Entity Tags: Michael Wilkes, Jerry Avorn, House Committee on Government Reform, US Food and Drug Administration

Timeline Tags: US Health Care

The Pharmaceutical Research and Manufacturers of America (PhRMA) acknowledges it has funded a series of television advertisements in support of legislation primarily written by Max Baucus (D-MT), chairman of the Senate Finance Committee, to reform US health care. The television ads are part of an agreement between the Obama administration, Baucus, and PhRMA in June, where the organization agreed to various givebacks and discounts designed to reduce America’s pharmaceutical spending by $80 billion over 10 years. PhRMA then set aside $150 million for advertising to support health care legislation. More progressive House Democrats such as Henry Waxman (D-CA) are pushing for stiffer drug industry givebacks than covered in the deal. PhRMA is led by Billy Tauzin, a former Republican congressman. Until recently, the organization spent some $12 million on ads by an offshoot coalition called Americans for Stable Quality Care, and aired television ads such as “Eight Ways Reform Matters to You.” PhRMA’s new ads will specifically support the Baucus bill. Many are critical of the deal, with James Love of the progressive research group Knowledge Ecology charging, “Essentially what the US got was not $80 billion, but $150 million in Obama campaign contributions.” [New York Times, 9/12/2009] Investigative reporter Matt Taibbi agrees with Love, accusing the White House of colluding with Baucus and Tauzin’s PhRMA to orchestrate a “big bribe” in exchange for the Democrats’ dropping of drug-pricing reform in the Baucus bill. Taibbi writes that in June, White House chief of staff Rahm Emanuel met with representatives from PhRMA and drug companies such as Abbott Laboratories, Merck, and Pfizer to cut their deal. Tauzer later told reporters that the White House had “blessed” a plan involving the $150 million in return for the White House’s agreement to no longer back government negotiations for bulk-rate pharmaceuticals for Medicare, and to no longer support the importation of inexpensive drugs from Canada. Taibbi writes that the White House worked with Baucus and PhRMA to undercut Waxman’s attempts to give the government the ability to negotiate lower rates for Medicare drugs. PhRMA’s ads are being aired primarily in the districts of freshmen Democrats who are expected to face tough re-election campaigns, and in the districts of conservative “Blue Dog” Democrats, who have sided with Baucus, Obama, and PhRMA to oppose the Waxman provision in favor of PhRMA’s own provision, which would ban the government from negotiating lower rates for Medicare recipients. [True/Slant, 9/14/2009]

Entity Tags: James Love, Henry A. Waxman, Americans for Stable Quality Care, Abbott Laboratories, Rahm Emanuel, Pharmaceutical Research and Manufacturers of America, Senate Finance Committee, Obama administration, Medicare, Max Baucus, Matt Taibbi, Pfizer, Merck, W.J. (“Billy”) Tauzin

Timeline Tags: US Health Care

Ordering 

Time period


Email Updates

Receive weekly email updates summarizing what contributors have added to the History Commons database

 
Donate

Developing and maintaining this site is very labor intensive. If you find it useful, please give us a hand and donate what you can.
Donate Now

Volunteer

If you would like to help us with this effort, please contact us. We need help with programming (Java, JDO, mysql, and xml), design, networking, and publicity. If you want to contribute information to this site, click the register link at the top of the page, and start contributing.
Contact Us

Creative Commons License Except where otherwise noted, the textual content of each timeline is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike