By Matt Viser, USA TODAY Washington – A day after the administration blocked the rollout for an experimental drug that could help cure AIDS patients, the administration on Monday announced it had approved the drug for use in the first wave of a two-year clinical trial for those with AIDS.
The approval comes after a delay of more than a year, when the White House said it wanted to complete a second phase of the trial in order to enroll patients before the end of the year.
The decision comes as the Obama White House faces criticism from health experts who say the administration is failing to provide adequate care for those on the waiting list for new drugs that have yet to be approved.
“The administration is wasting precious time trying to get this drug approved,” said Michael Greger, a senior vice president at the nonprofit AIDS Healthcare Foundation.
“People with HIV, those who have been waiting for this, are going to be disappointed and not going to get what they want.”
The announcement comes as Congress and the administration have been sparring over how to deal with the AIDS epidemic and its potential economic impact.
Some Republican lawmakers want to block any new drug approval from coming until the economy improves, and some Democrats want to delay approval until 2020.
The Obama administration has said it has decided to use the money to speed the drug’s approval.
The drug, called valtrexone, was developed by GlaxoSmithKline Inc. and Merck & Co. and is designed to help people with HIV treat the disease.
It is approved for use to treat HIV-positive patients in two phases: phase 1 involves patients with HIV infection who have not received new drugs for at least six months, and phase 2 includes patients who have received two or more drugs for 12 months.
The drugs have proven effective in some patients, including those who are living with HIV for a year or more.
But Glaxos’ approval came after a lengthy public outcry over delays in the development of the drug, which has had problems with safety and side effects.
The government is trying to speed up approval for a second Phase 1 trial, which could start in early 2021 and involve as many as 4,000 people.
The second trial will include patients with more serious infections and those who were recently treated for HIV.
The FDA says it expects to finish its phase 1 trial by the end at the end on April 20.
GlaxoS, the company that developed valtrx, has been under pressure from lawmakers and the pharmaceutical industry for delays in getting the drug approved.
In recent weeks, some lawmakers have called for a review of how the FDA handles the approval process, and a series of congressional hearings have focused on the approval.
Congress has also pushed for the government to provide funding for additional testing and testing centers.
The administration has not provided details on the funding.
“It is essential that the FDA and Congress provide funding to provide additional testing centers to expedite the approval of this drug, and to provide greater oversight and oversight of the approval,” the White in Congress Office said in a statement Monday.
The agency did not say how much it had spent on the testing and centers.
On Monday, the WhiteHouse said that it has not received any money from the administration to cover costs related to the phase 2 trial.
The statement came after the Whitehouse said it would spend $100 million to help cover costs of the phase 1 and phase 3 trials.
The announcement by the WhiteHousing and Urban Development Office also said it had awarded a $500,000 grant to a New Jersey-based firm to provide assistance for the FDA in completing the phase 3 trial.
But it did not give a total amount.
The department did not respond to questions about how much the administration had spent or how many people have received a trial of valtxor.
Glixo said Monday that the drug would be available to the first 10,000 participants of the Phase 1 phase 3 study.
The company did not have an estimated cost for the second phase 2 phase 3 phase 3, but it said it expects the costs to be between $2 million and $2.5 million.
The WhiteHouse had previously said that if the administration approves the drug and it is approved in two years, it would be used in the phase 4 trial, in which the administration expects the drug to be used for an average of three years.
That trial is expected to begin by March 2019.
The phase 3 clinical trial is scheduled to run for at most two years.
The $100,000 in grants is part of a larger $1.6 billion program to speed drug approval for more than 3,000 new AIDS drugs approved by the Food and Drug Administration since January 2010.
The Department of Health and Human Services has not yet announced whether it will spend money on the phase two trials.