January 28, 2010
The Food and Drug Administration is calling on pharmaceutical firms to give more attention to the potential for abuse of new drugs when subjecting them to pre-market testing. The agency this week released a draft of new voluntary guidelines to assist drug makers in figuring out which compounds should be placed under the Controlled Substances Act, which regulates the handling, record-keeping and dispensing of controlled substances. The guidelines urge researchers to look beyond traditional indicators such as whether a compound is addictive to other characteristics that could lead to abuse.
June 11, 1991
When Dr. David Kessler took over recently as the new head of the federal Food and Drug Administration, he inherited a budget -- $690 million -- that virtually matched that of his previous institution, the Albert Einstein Hospital in New York, where he had been chief of medicine. But there's a big difference in what those budgets must cover. Unlike a hospital, the FDA wields vast power, with its responsibility for the safety and quality of goods that make up one-quarter of the nation's gross national product.
December 3, 2013
The U.S. Food and Drug Administration recently published a draft proposal that would remedy an injury the Supreme Court dealt to generic-drug consumers two years ago in a case known as Pliva v. Mensing. In that decision, the court held that federal law prevented generic manufacturers from independently revising inadequate, inaccurate and out-of-date warning labels on their products, as the manufacturers of brand-name drugs are able to do. The ruling had the net effect of taking away any legal recourse from consumers who were harmed by those drugs because of poor safety labels.
December 29, 1994
In their zeal to trim the federal bureaucracy and reduce heavy-handed regulation, Republican leaders in Congress need to tread carefully. Just because an agency like the Food and Drug Administration doesn't approve new products as swiftly as corporate marketing departments would like is no reason to cripple an agency that performs a vital function -- often as vital as the difference between life or death.Sun Washington Correspondent Michael A. Fletcher reports that the incoming speaker of the House, Newt Gingrich, thinks the FDA should be "torn down" because it is "the leading job killer in America."
November 21, 2004
A SENATE committee was treated last week to one of those rare, Mr. Smith Goes to Washington moments, when a seemingly earnest public servant blows the whistle on a government agency that has lost its way. Shockingly, but somehow not surprisingly, the Food and Drug Administration was described by a long-term employee as so hamstrung by management conflicts and sympathy for the industry it regulates that it cannot perform its mission of protecting the...
November 27, 2005
If practice makes perfect, the Food and Drug Administration may finally be on its way to regaining confidence in its ability to protect public safety. The conflict-ridden agency - both shill for the pharmaceutical industry and stooge for White House political shop - can hardly afford any more steps backward. In naming veteran FDA official Kathleen Uhl to head the office of women's health, the Bush administration has at least met what would seem to be the minimum requirements for the post: She is a woman and a physician.
October 5, 1991
Important questions remain about the Food and Drug Administration, despite the aggressive approach its new commissioner, Dr. David A. Kessler, has taken on truth-in-promotions. The first has to do with efficiency, a buzzword during the Reagan-Bush years.It has been well documented that approval of new pharmaceuticals drags. In the competitive environment in which American manufacturers find themselves, that means new products often get introduced abroad before U.S. approval can be won, even if the drugs were developed by domestic firms.
December 31, 1993
PharmaKinetics Laboratories Inc., a Baltimore-based generic-drug development company, said yesterday that it has been warned by the Food and Drug Administration that it is in violation of guidelines governing drug testing.The FDA said in a Dec. 28 letter to the company that PharmaKinetics had failed to follow established rules for drug tests involving people. Specifically, the federal agency criticized the company for failing to document the medical reasons for including in tests in 1990 and 1991 people who did not meet the company's own criteria for such volunteers.
April 28, 2007
PHILADELPHIA -- In a widely expected move, Merck & Co.'s arthritis drug Arcoxia was rejected by U.S. regulators yesterday amid concerns that it could pose some of the same cardiovascular risks as the company's withdrawn pain-reliever Vioxx. The Food and Drug Administration said it wanted more data showing that the benefits outweighed potential risks before approving Merck's successor drug to Vioxx, the company said. Merck said the FDA issued a "non-approvable" letter for Arcoxia stating that "Merck would need to provide additional data in support of the benefit-to-risk profile for the proposed doses of Arcoxia in order to gain approval."
November 16, 1990
WASHINGTON -- A task force set up by the pharmaceutical industry called on the Food and Drug Administration yesterday to revamp the approval process for new generic drugs and beef up enforcement against drug testing fraud to help restore public confidence in the generic drug industry.The private review board, formed in the wake of revelations two years ago that several generic drug firms had bribed FDA officials and had supplied false information to them to win approval for their products, said they wanted the FDA to guarantee the integrity of the testing process.