Regulators have permitted the use
of unapproved drugs in previous infectious disease epidemics — for instance, during the 2009 H1N1 epidemic, when the FDA allowed the emergency use of the antiviral drug peramivir.
Twelve unlicensed drug dealers have been rounded up for producing and distributing herbal concoctions, unlicensed and
unapproved drug at Ashaiman,...
Together with his transsexual business partner Rayon (Leto), he forms the Dallas Buyers Club to
sell unapproved drugs that might give the HIV - positive community a fighting chance.
Powerful personal stories of patients cured
by unapproved drugs or who die before they can get access to an experimental drug have swayed many lawmakers from both parties.
He has tussled in particular with the FDA, which in 1987 raided his supplement company's warehouse, leading to an indictment for allegedly conspiring to
import unapproved drugs into the country; the indictment was eventually dropped.
His film takes the form of a journal covering the year in which he undertook clinical trials
with unapproved drugs to treat HIV - related Hepatitis C. Back in the Seventies, Susan Sontag cautioned that «the healthiest way of being ill is one purified of metaphoric thinking.»
Rights are granted «only with respect to the making, constructing, using and selling» of the approved drug containing the medicinal ingredient, or combination of medicinal ingredients included in the
SPC. Unapproved drugs are not protected.
In another case, following a decision by a government official to withdraw a particular drug from availability through the Special Access Programme (which provides an exceptional means for patients to
access unapproved drugs), patients sought review on the grounds that the official acted outside the scope of his statutory authority.
In 2014, she revealed the agonizing decision - making behind Compassionate Use
of unapproved drugs, and in 2016, she reported extensively on drug pricing controversies and the impact of politics on development of new medicines.
Twelve unlicensed drug dealers have been rounded up for producing and distributing herbal concoctions, unlicensed and
unapproved drug at Ashaiman, in the Greater Accra region.
In response to reports that women may be using
this unapproved drug, to increase milk production (lactation), the WHO and FDA are warning breastfeeding women of safety concerns as «there have been several published reports and case studies of cardiac arrhythmias, cardiac arrest and sudden death in patients receiving an intravenous form of domperidone that has been withdrawn from the market in a number of countries.»
Many legal experts and ethicists argue that access to
unapproved drugs would undermine the scientific process that determines which drugs are effective as well as the FDA's ability to determine drug safety.
In August, the U.S. Court of Appeals for the District of Columbia upheld (pdf) the power of the FDA to control patients» access to
unapproved drugs.
An ethical panel convened by the World Health Organization (WHO) broke new ground today when it said that using experimental,
unapproved drugs or vaccines in the current Ebola outbreak is ethical — assuming a set of criteria is met.
Other questions include who will pay for
the unapproved drugs, who can give consent for using them, and how companies will be protected from liabilites should the drugs have harmful side effects.
And though the FDA does continues to monitor the industry — in 2007, the agency warned three manufacturers that their red yeast rice products were
unapproved drugs — the woolly marketplace for supplements should make consumers wary.
The FDA has shut down natural desiccated thyroid drug production and distribution by three major firms, and is now calling the century - old natural remedy an «
unapproved drug.»
In 2009, the World Anti-Doping Agency (WADA) started removing asthma medications from its list of
unapproved drugs.
Sensing a moneymaking opportunity selling
the unapproved drugs to ailing people in the U.S., Woodroof starts up the «Dallas Buyers Club», in which the medication is free but the membership to the club is $ 400.
His Dallas Buyer's Club is essentially a way for him to charge for monthly memberships in order to give away
unapproved drugs for treating HIV and AIDS to his members.