In the Field: News - Pharmaceutical Technology

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PharmTech Europe

In the Field: News

Pharmaceutical Technology
Volume 3, Issue 32


Changshu City is a county-level city located in the southeast of Jiangsu Province. Surrounded by Shanghai in the east, Suzhou and Kunshan to the south, Wuxi to the west, and the Yangtze River to the north, Changshu has a population of 1.04 million and a GDP that ranks among the top 10 counties in China. In fact, the Jiangsu Changshu Southeast Economic Development Zone is home to some 2000 foreign-funded enterprises from 50 different countries and regions. For those considering an office or home location there, Changshu has been honored as a National Model City for Living Environment and National Ecological Model Area.

São Paulo, the capital of Brazil, is the third largest populated city in the world and is expected to be the 13th richest city by 2020. A key global financial center, São Paulo's economy has a growing services sector. The government is planning to build the first ethanol-duct in the world in São Paulo.

Whatever Happened to...the Case Regarding Terminally Ill Patients?

by Angie Drakulich

In Pharmaceutical Technology's October 2007 issue, we wrote "Who's in Charge?" about a decision by the US Court of Appeals for the District of Columbia (Abigail Alliance v. Andrew Von Eschenbach), which stated that the due process clause of the Fifth Amendment does not extend to terminally ill patients who seek experimental drugs. The Abigail Alliance for Better Access to Developmental Drugs had argued that due process should protect "persons in mortal peril" to "try to save their own lives." The Court rejected that argument.

Since that time, the alliance, along with the Washington Legal Foundation, filed a petition for a writ of certiorari. They asked the US Supreme Court to reinstate a 2006 decision by the appeals court panel that a terminally ill patient has a constitutional right to access investigational drugs when there are no other FDA-approved treatment options.

The US Food and Drug Administration does offer a "compassionate use" provision in which terminally ill patents can access experimental drugs, but it is not very effective. The agency grants investigational drug access to only about 650 people a year for all drugs and diseases, according to an April 2007 Wall Street Journal article—compare that number to the 550,000 cancer patients who die each year.

Despite these statistics, FDA and the Bush administration urged the Court not to hear the Alliance's case. US Solicitor General Paul D. Clement, for example, wrote in a court brief that, "allowing patients to obtain and use unproven drugs carries a host of risks and potential detriments for the public health." He offered FDA's expanded drug access program as an alternative. In late 2006, the agency began developing a Proposed Rule on Expanded Access to Investigational Drugs for Treatment Use. Public comments were due this time last year but the rule is still pending.

In mid-January, the Supreme Court officially declined to hear the case. So until another case comes along, access to experimental drugs for the terminally ill is in the hands of FDA.


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