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The FDA is warning the medical community about new risks associated with taking drugs used to treat migraines together with antidepressant medications and possible drawbacks of taking antidepressants while pregnant.
The biotech industry’s hopes for additional federal stem cell research funding were dashed yesterday as President Bush used the first veto of his presidency to send a bill back to likely defeat in Congress.
Sen. Chuck Grassley (R-Iowa) is accusing the agency of actively working with Merck to discredit a Vioxx whistleblower and is asking the HHS Office of Inspector General to investigate this claim.
The FDA’s historical developments have led the agency to where it is today — balancing between industry’s call for accelerated approval of new drugs and the public’s concerns with safety, facing growing criticism over its relationship with industry and fighting for Senate confirmation of its commissioner.
The story of the FDA begins with the burgeoning role of science in the federal government in the 1830s, said Peter Barton Hutt, senior counsel at Covington & Burling and former FDA general counsel.
Abstract: The FDA celebrated the 100th anniversary of the passage of the 1906 Pure Food and Drug Act on June 30, but its birth and subsequent growth was based on three factors — public tragedies, political wrangling and court decisions. These factors are likely to be the foundation on which the agency’s future is built as well. The deaths of 13 children in New Jersey in 1901 from diphtheria antitoxin contaminated with tetanus, the sulfanilamide incident of the late 1930s and the thalidomide scare of the early 1960s led not only to the creation of the agency, but also to congressional action that ultimately gave the FDA the authority to require that drugs be both safe and effective, the same standard it applies today. Equally important, however, have been the legal rulings that established — and then tempered — the agency’s authority over the years. The FDA’s modern enforcement authority arrived through a pivotal 1943 Supreme Court decision, U.S. v. Dotterweich, which established that the FDA did not have to show that corporate officials intended or even knew of violations in order to prosecute them for violations of federal food and drug law. Later in the 20th century, the AIDS epidemic, a generic drugs scandal involving FDA officials and the creation of drug industry user fees would lead to profound change at the agency, turning it into the institution that exists today. Looking ahead, the agency faces the challenges of an increasingly global regulatory environment and industry’s move toward personalized medicines.
A senior FDA official’s speech urging the agency to pull back from requiring risk management plans as a part of the drug approval process signals a major change in the FDA’s thinking on drug safety, an industry observer says.
The Supreme Court has rejected the Federal Trade Commission’s (FTC) appeal to hear a case that could have ended the practice of reverse payments, spurring swift congressional action to outlaw such agreements.