Pharmacapsules @ Gowlings - August 21, 2009

Contents

FDA To Speed Up Inspection And Warning Process

U.S. Patients Receive Greater Access to Unapproved

Medications

Recent Cases

FDA To Speed Up Inspection And Warning Process

By: Isabel Raasch

On August 6, 2009, the USFDA's top official Margaret Hamburg

vowed to speed up the reporting of warnings related to problems

found during inspections and to act more aggressively in serious

cases that could harm consumers and patients. The announcement

follows criticism of the delays caused by the agency's previous

requirement that all warning letters be reviewed by the

agency's top lawyer before being sent to manufacturers. This

procedure will now only be used for certain legally complex cases.

Under the new policy, the agency will strive to send warning

letters promptly, whereupon companies will have up to 15 working

days to respond before the agency takes further action. Ms. Hamburg

also stated that the agency will move quickly to close cases after

problems found during inspections have been resolved and that it

would make such information public.

For more information, please see:

http://www.reuters.com/article/rbssHealthcareNews/idUSN0642179520090806?sp=true

U.S. Patients Receive Greater Access to Unapproved

Medications

By: John Norman

Seriously ill patients will have greater and easier access to

unapproved medicines due to new USFDA regulations. The new rules

establish who is eligible for these new experimental drugs and when

manufacturers can charge for them. The FDA predicts a 50% increase

in individual applications, and a 25-50% increase in applications

from groups of patients. It is also hoped these new rules will

encourage companies to provide experimental medicines outside of

clinical trials.

For more information, please see:

http://www.alertnet.org/thenews/newsdesk/N12141146.htm

Recent Cases

By: Beverley Moore

Purdue v. Pharmascience;

merits of a 55.2 proceeding; 2009 FC 726;

oxycodone; July 16, 2009

The Court granted an order of prohibition to Purdue in the face

of Pharmascience's allegations that the patent was invalid.

Regarding the anticipation allegation, the Court found that none

of the alleged documents met the disclosure requirement. In

considering obviousness, the Court applied the Supreme Court's

test in Sanofi and looked at testimony from the inventors

as well as the experts. The Court then went on to hold that a

considerable amount of work had been required in order to achieve

the invention. Furthermore, the trials of the inventors were not

routine and it was not...