Welcome, Guest. Please login or register.
January 16, 2018, 07:56:08 PM

Login with username, password and session length

  • Total Posts: 725179
  • Total Topics: 59104
  • Online Today: 315
  • Online Ever: 1421
  • (August 13, 2016, 05:18:44 AM)
Users Online
Users: 2
Guests: 268
Total: 270


Welcome to the POZ Community Forums, a round-the-clock discussion area for people with HIV/AIDS, their friends/family/caregivers, and others concerned about HIV/AIDS.  Click on the links below to browse our various forums; scroll down for a glance at the most recent posts; or join in the conversation yourself by registering on the left side of this page.

Privacy Warning:  Please realize that these forums are open to all, and are fully searchable via Google and other search engines. If you are HIV positive and disclose this in our forums, then it is almost the same thing as telling the whole world (or at least the World Wide Web). If this concerns you, then do not use a username or avatar that are self-identifying in any way. We do not allow the deletion of anything you post in these forums, so think before you post.

  • The information shared in these forums, by moderators and members, is designed to complement, not replace, the relationship between an individual and his/her own physician.

  • All members of these forums are, by default, not considered to be licensed medical providers. If otherwise, users must clearly define themselves as such.

  • Forums members must behave at all times with respect and honesty. Posting guidelines, including time-out and banning policies, have been established by the moderators of these forums. Click here for “Am I Infected?” posting guidelines. Click here for posting guidelines pertaining to all other POZ community forums.

  • We ask all forums members to provide references for health/medical/scientific information they provide, when it is not a personal experience being discussed. Please provide hyperlinks with full URLs or full citations of published works not available via the Internet. Additionally, all forums members must post information which are true and correct to their knowledge.

  • Product advertisement—including links; banners; editorial content; and clinical trial, study or survey participation—is strictly prohibited by forums members unless permission has been secured from POZ.

To change forums navigation language settings, click here (members only), Register now

Para cambiar sus preferencias de los foros en español, haz clic aquí (sólo miembros), Regístrate ahora

Finished Reading This? You can collapse this or any other box on this page by clicking the symbol in each box.

Author Topic: FDA Proposes Broadening Access to Drugs  (Read 2880 times)

0 Members and 1 Guest are viewing this topic.

Offline J220

  • Member
  • Posts: 587
FDA Proposes Broadening Access to Drugs
« on: December 11, 2006, 02:07:08 PM »
FDA Proposes Broadening Access to Drugs

Published: December 11, 2006
Filed at 12:47 p.m. ET

WASHINGTON (AP) -- Greater numbers of seriously ill patients could get experimental medicines under proposed federal guidelines released Monday that also would clarify when drug companies could charge for the medicines.

The revised guidelines lay out in greater detail when unapproved drugs would be available to patients with no other options to treat a life-threatening or serious disease or condition, the Food and Drug Administration said. The FDA would have to be satisfied that the potential benefit of the treatment justifies its potential risks.

If adopted, the guidelines would spell out that drugs could be available during all stages of drug development, including during initial, phase-one testing. During that step, experimental drugs are tested in as few as 20 people. Just 10 percent to 15 percent of phase-one drugs ultimately win FDA approval.

Since the 1970s, the FDA has made experimental drugs available to either individuals or large groups of patients under compassionate use programs. The revised guidelines, subject to comment for 90 days, would further describe all the circumstances in which access would be allowed, including to small groups of patients.

''FDA hopes this proposal will increase awareness in the health-care community of the range of options available for obtaining experimental drugs for seriously ill patients,'' said Dr. Janet Woodcock, FDA's deputy commissioner for operations.

A drug also could be made available on a wider basis according to the seriousness of the disease it targets and the number of patients involved.

To defray the high costs of developing the treatments, drug companies, research institutions and other drug developers would be able to charge patients in some cases for their drugs while under study. The FDA said doing so would encourage them to provide early access to drugs by allowing them to recuperate some of their costs. Drug companies can now charge for experimental drugs, but generally do not.

Next year, a federal court will rehear a 2003 case brought by the Washington Legal Foundation and the Abigail Alliance for Better Access to Developmental Drugs in seeking broader access to drugs that have undergone preliminary safety testing but have yet to be approved by the regulatory agency.

Woodcock declined to comment on the suit.

The issue has dogged the FDA for decades. In the late 1970s, terminally ill cancer patients and their spouses sought access to Laetrile, a then- and still-unapproved drug, eventually suing the FDA in a case that landed in the Supreme Court.

In 1979, the top Court ruled unanimously that there should be no exemption to the FDA's safety and effectiveness standards, which all drugs must meet, for medicines sought by terminally ill patients.

Sen. Sam Brownback, R-Kan., introduced legislation last year that would require the FDA to create a three-tiered approval system that would expand access to experimental drugs for patients with serious or life-threatening conditions and diseases.
"Hope is my philosophy
Just needs days in which to be
Love of Life means hope for me
Born on a New Day" - John David

Offline Ihavehope

  • Member
  • Posts: 1,366
  • Yes, I'm a cry baby, AND WHAT?
Re: FDA Proposes Broadening Access to Drugs
« Reply #1 on: December 15, 2006, 04:16:13 PM »
When you are in a life or death situation it is best to be treated with something that has some potential to aid you than sit and wait for worse things to occur.

I am all for clinical trials and phases but the FDA needs to eliminate or shorten a phase to hurry up the process.
Infected: April 2005
12/6/06 - Diagnosed HIV positive
12/19/06 - CD4 = 240  22% VL = 26,300
1/4/07 - CD4 = 200 16% VL = ?
2/9/07 = Started Kaletra/Truvada
3/13/07 = CD4 = 386 22% VL ?

Offline AtomicA

  • Member
  • Posts: 156
  • that's Famous with an F
Re: FDA Proposes Broadening Access to Drugs
« Reply #2 on: December 21, 2006, 03:43:54 AM »
would the people recieving these ultra-experimental drugs be considered as part of the testing itself? possibly getting these drugs through trials and into market even faster?


Terms of Membership for these forums

© 2017 Smart + Strong. All Rights Reserved.   terms of use and your privacy
Smart + Strong® is a registered trademark of CDM Publishing, LLC.