Tampa, FL (July 2) —The International Society for Pharmaceutical Engineering
(ISPE) launched a new initiative called Product Quality Lifecycle Implementation (PQLI) at its Washington Conference held
in Washington D.C. in early June.
ISPE says in its role as a "catalyst for change," the association is working with regulators in the United States, Europe,
and Asia-Pacific to help industry find solutions to the challenges in implementing guidances of the International Conference
on Harmonization (ICH). The goal of these sessions is to begin to define areas where industry will be able to provide the
technical framework for the implementation of Quality by Design in regulatory submissions.
London (June 21)—
The European Medicines Agency
agreed to follow up with patients affected by
(Basel, Switzerland)'s "Viracept" (nelfinavir), which was recalled in June. The drug, an antiretroviral medicine used to treat
HIV-1 infected patients older than three years, was recalled from the European market after it was learned that some batches
had become contaminated with ethyl mesilate during manufacturing. Ethyl mesilate is harmful to DNA.
The agency's Committee for Medicinal Products for Human Use (CHMP) concluded on June 13 that there were insufficient data
to establish which doses of ethyl mesilate might be toxic to humans and requested that Roche carry out animal studies to calculate
this level more precisely. Preliminary results are expected by the end of 2007.
CHMP also asked the company to identify the group of patients exposed to the contaminated batches of Viracept so that the
committee can follow up and monitor their situation. CHMP plans to monitor all patients exposed to high levels of the contaminant
in batches released since March 2007, as well as all pregnant women and children ever exposed to Viracept, including those
The agency also recommended that the European Commission suspend Viracept's marketing authorization. Until the manufacturing
issues are identified by CHMP and resolved, the drug will not be available to patients.
Rockville, MD (June 18)—
The US Food and Drug Administration
(Rockville, MD), the European Commission (EC, Brussels, Belgium), and the
European Medicines Agency
(EMEA, London agreed to extend cooperative activities to the areas of pediatrics and medicinal products for rare diseases
(i.e., orphan drugs). These activities will include scientific dialogue on extensions of therapeutic indications and risk-management
According to a prepared statement, the agreement "builds on the achievements in cooperation on vaccines, oncology, and pharmacogenomics"
with the objective of "promoting and protecting public health, reducing regulatory burden and costs, and bringing innovative
products to patients in a timely manner."
The European Union recently adopted legislation governing pediatric therapeutics. During a meeting with FDA in mid-June, the
EU finalized its "Principles of Interactions" document, which aims to facilitate timely exchange of scientific information
and ethical issues. The meeting also involved a discussion of "upstream regulatory cooperation on new medicines legislation."
Although no details of this discussion were released, the agencies announced plans to hold a meeting on a "Transatlantic Workshop
on Administrative Simplification in Medicines in Regulation" on November 28 in Brussels.
Washington, DC (June 19)—The House Subcommittee on Health voted to forward the amendments to the Prescription Drug User Fee Act to the House Committee
on Energy and Commerce. The bill was altered slightly in committee. Langauge that would have eliminated the
US Food and Drug Administration's
(Rockville, MD) preemption authority over state laws was removed, as was a provision limiting exclusivity to six months for