8:14 AM, Apr 14, 2014 • By MICHAEL ASTRUE
Politics at its best brings people and groups together in unexpected ways. Although the Reagan administration responded sluggishly to the emergence of HIV in the 1980s, its last FDA commissioner, Frank Young, reached out to the very HIV activists who had for years made life miserable for him and other HHS officials.
Young’s outreach was an act of courage and vision for which he never received appropriate credit. Most of Young’s senior staff saw nothing in the HIV epidemic that required urgent reconsideration of the agency’s unreasonably burdensome rules and practices that had killed development of countless innovative therapies.
Young bravely overrode his staff and created a regulatory “fast track” for novel HIV therapies. His reform explicitly embraced the principle that the FDA would approve HIV drugs on the basis of “surrogate endpoints”—biological data that were likely, but not proven by past FDA standards, to measure clinical improvement. For HIV the FDA relied on T-cell counts as a measure of the strength of a patient’s immune system.
Young’s shift in policy quickly led to the approval of two HIV drugs; they were mediocre drugs by today’s standards, but they bought time for desperate patients until far superior drugs of the 1990s began to make HIV a substantially manageable disease. His initiative also gave patients an alternative to the technically illegal black-market stores called “buying clubs,” where one of their most popular products, ribavirin, was actually accelerating the death of the customers. It is worth noting that two of the start-up companies that developed HIV protease inhibitors in the 1990s after the creation of the fast track have gone on to become developers of very effective drugs for another scourge with similar biological mechanisms, hepatitis C.
In 1989 Vice President Quayle’s Competitiveness Council, led by future congressman David McIntosh, began work on a plan to extend the HIV approval rules to other life-threatening diseases. When McIntosh transmitted the draft 10-point plan to the FDA, the FDA truculently replied that it could only support minor proposed changes in one point. HHS Secretary Louis Sullivan did not want to aggravate friction with FDA commissioner David Kessler by overriding him.
I then received a quiet but emotional call from a senior White House official who expressed to me President Bush’s frustration at the FDA’s intransigence and asked me to try to broker a compromise. Accelerating breakthrough therapies was not just an abstract policy dispute for President Bush—he had lost a young daughter to a rare cancer.
Revisions responsive to some FDA concerns and meetings with senior FDA officials did not break the deadlock. I then went in to talk with Kessler, who initially defended the agency party line. For rhetorical purposes, I asked David if he wanted to revoke the HIV fast track, which he had no interest in doing. I then pressed him on the moral distinction between accelerating drugs for HIV patients but not for patients dying of cancer and other fatal diseases. Knowing David was a pediatrician, I also shamelessly included some devastating diseases of childhood.
David had no answer to my morality question. His face softened, and he relented. In 1991 the FDA approved Genzyme’s Ceredase for a very rare fatal condition called Gaucher disease in a non-blinded trial of only 12 patients; the drug has allowed almost all patients to lead almost normal lives. In 1992 HHS substantially adopted the McIntosh plan and allowed accelerated approval of drugs for all life-threatening diseases.
Unfortunately, the battle had only begun. The FDA’s lead examiner for the first drug to be approved under the accelerated approval regulations recommended against approval, but was overruled by a more senior official, Dr. David Finbloom. This pattern continued for many years with the same examiner and others putting up roadblocks against innovative therapies until Finbloom bulldozed through those roadblocks. As a result of his vision and determination, critically important new drugs for cancer, multiple sclerosis, and rare diseases became available to patients under the accelerated approval regulations. When David Finbloom died in 1999 (of the same rare brain cancer that killed Senator Ted Kennedy and my father), America lost one of its greatest patient advocates.
2:05 PM, Mar 21, 2014 • By JIM SWIFT
The Food and Drug Administration is soliciting information and comment on brochure technology it's exploring as part of its mandate to implement the Tobacco Control Act, a law signed by President Obama during his first year in office.
8:25 AM, Feb 27, 2014 • By DANIEL HALPER
First Lady Michelle Obama wants to make changes to the Nutrition Facts label. It is all "part of an effort to help families make healthier choices," according to the White House.
8:29 AM, Jan 3, 2014 • By JERYL BIER
The Food and Drug Administration is seeking a small business to potentially supply the federal agency with a chewing gum tester. Despite the frivolous sounding nature of the announcement, the search is a serious one, and apparently a growing need.
Dec 9, 2013, Vol. 19, No. 13 • By THE SCRAPBOOK
It’s difficult to think of a company doing anything as gee-whiz neat as 23andMe. The Mountain View, Calif., firm, which opened its doors to the public in 2007, provides comprehensive genetic tests to anybody with $99 to spend. Customers send in a saliva sample and about six weeks later get access to a detailed website explaining their unique genetic code along with an opportunity to connect with (usually distant) relatives who have also done business with 23andMe.
The irrational hostility to e-cigarettes.Aug 5, 2013, Vol. 18, No. 44 • By ETHAN EPSTEIN
Smokeless, odorless, and, indeed, tobacco-less, electronic cigarettes, or “e-cigarettes,” in common parlance, are projected to become a $1 billion industry this year. Yes, that’s “electronic” cigarettes: battery-powered gadgets that convert liquid nicotine into vapor, which the user inhales. The act is known—unfortunately, if accurately—as “vaping.” (It’s important to note that one doesn’t smoke an e-cigarette.) Some e-cigs are made to closely resemble actual cigarettes—they have the same shape and color and even an LED light at the end, designed to simulate a lit butt.
2:35 PM, Jun 20, 2013 • By JERYL BIER
The Food and Drug Administration's Office of Criminal Investigations is soliciting bids for "Data Mining and Targeting Software" to help in its efforts to combat illegal trafficking in cigarettes and other tobacco products.
9:56 AM, Apr 2, 2013 • By DANIEL HALPER
The federal government will now allow companies that sell "nicotine replacement therapy (NRT) products," such as Nicorette, not to put warning labels on their merchandise, the Food and Drug Administration announced. The change, the FDA now admits, is because the warnings, which were mandated for the last 30 years, were misguided from the very beginning.
12:55 PM, Dec 13, 2012 • By ALEXANDER KAZAM
The FDA is raising hackles over the equivalent of an espresso shot in a bottle: the popular 5-Hour Energy drink that has billions of dollars in sales over the past decade.
1:19 PM, Jul 3, 2012 • By DANIEL HALPER
"The U.S. Food and Drug Administration today approved the OraQuick In-Home HIV Test, the first over-the-counter, self-administered HIV test kit to detect the presence of antibodies to human immunodeficiency virus type 1 (HIV-1) and type 2 (HIV-2). HIV is the virus that causes acquired immune deficiency syndrome (AIDS)," a press release from the FDA states.
The Obama administration targets food marketed to children.Aug 8, 2011, Vol. 16, No. 44 • By KATE HAVARD
The Obama administration is after your Lucky Charms, or at least your children’s. The public comment period closed on July 14 for a set of “voluntary” guidelines for the marketing of food to children. If adopted, these rules will transform the advertising of breakfast cereals.
A recipe for indifference.12:50 PM, Apr 6, 2011 • By DAVID GRATZER
What if you passed a regulation, and nobody cared? Obesity is quickly emerging as a major policy issue, with related health costs consuming 10 cents on every health dollar – and rising. Policymakers, then, are eager for ideas. Top of the list: regulations to force chain restaurants to post calorie counts on their menus.
1:10 PM, Nov 29, 2010 • By JIM PREVOR
Today, the Senate is likely to vote on the Food Safety Modernization Act of 2010 (S510). But the bill is little more than an enormous grant of money and power to the Food and Drug Administration and a lot of reporting burdens imposed on the private sector. Those who favor a smaller, leaner government should oppose it.
4:00 PM, May 7, 2010 • By MARY KATHARINE HAM
Anthony Bourdain, celebrity chef and host of the Travel Channel's very popular "No Reservations" does not mince words about the possibility future overbearing salt regulation.
In this otherwise depressing Time piece that, among other creepy sentiments, asserts that "we can be trained" to get by with less sodium and calls salt a dietary "cocaine," Bourdain's delightfully politically incorrect sentiment is, well, the salt and the light.