The Drug Approval Process... WAS: Re: FDA Approval

[Murray Charters <Murray_Charters@xxxxxxxxx>]

On 3 Nov 2000, at 10:29, Marjorie L. Moorefield wrote:
> Good Morning Sid,
> Since Canada and most, if not all European countries have
> socialized medicine, how can whatever they do be compared
> to our "Free Market" Health Care?
> just me,
> Marjorie
>

Hi Marjorie and All,
We sorta have socialized medicine but with free market elements.
And at a BIG cost...

But the part Sid wanted to compare was the bureaucracies that
control the new drug approval process...  In the US - the FDA.
In Canada - Health Canada's Health Protection Branch HPB
Both require multi-phase clinical trials...
Both require double blind studies over at least a year...
Both are conservative govt. organizations...
Perhaps someone who knows the processes first hand will comment.
I personally think they are pretty similar in function.

Here is a PHARMA press release from March...

March 30, 2000
Canada's Health Care System Reduces Access to New Technology
and Impacts Quality if Care for Patients, Says Study

Washington, D.C. - Canada?s government-controlled health care system,
with its strong emphasis on cost-containment, has adverse consequences
on patient access to appropriate treatments, including innovative
prescription drugs. That?s the key conclusion of a new study conducted
by The Lewin Group for the Pharmaceutical Research and Manufacturers of
America (PhRMA).

"U.S. policymakers should be aware of the Canadian experience with health
care cost-containment policies when  considering changes to our own
system," said PhRMA President and CEO Alan F. Holmer. "We should learn
from  Canada?s mistakes and not make the mistake of emulating that system."

According to the study authors, the Canadian experience suggests that any
cost savings that accrue from price controls are associated with a decline in
the quality of health care and with public dissatisfaction. In fact, a recent
survey found that 78 percent of Canadians believe their health care system is
"in crisis."

The Lewin Group study highlights many other problems in the Canadian
health care system:

Long waits for regulatory approval - Canadians wait on average 7 months
longer than Americans for new  medicines to be approved.

Long waits for coverage of medicines - Even after a medicine is approved
by Canada?s drug regulatory agency, patients must wait an average of 5 to
13 months longer before the medicine is put on each province?s formulary,
or list of covered drugs.

Cost-containment tools used by provincial governments limit the number
of medicines available to patients. For  example, patients in British Columbia
are restricted to two medicines as first-line therapy for arthritis. Three
anti-arthritic drugs widely used in the U.S. are not covered under any
circumstances.

According to Canadian patient groups, health problems have resulted from
switching patients from medicines not on the formulary to covered medications.

Canadians also experience long waits for physician visits, surgery procedures
and high-tech diagnostic procedures. For example, Canadians wait an average
of nearly 6 months for cardiovascular surgery and 5 months  for a magnetic
resonance imaging procedure (MRI).

The study warns U.S. policy-makers that tinkering with our own system could
result in similar quality problems,  stating that "the delays in pharmaceutical
access, coverage and reimbursement inherent to the Canadian system could be
replicated in the U.S. if the federal government interferes with the free-market
delivery of pharmaceuticals."



Drug Development and Approval Process
Phases of Product Development
It takes 12 years on average for an experimental drug to travel from lab to
medicine chest. Only five in 5,000 compounds that enter preclinical testing
make it to human testing. One of these five tested in people is approved.


FDA Website


U. S. Food and Drug Administration ?
Center for Drug Evaluation and Research


FDA - CDER


>From Test Tube To Patient:
New Drug Development in the United States


Benefit Vs. Risk: How FDA Approves New Drugs


Drug Approval Application Process


FDA Improves Drug Approval Process


Regulatory - International Sites
(Check this one out Sid...)


Canada - Health Protection Branch HPB


Therapeutic Products Programme: TPP-Web


An Overview of the Product Licensing Framework II
September 1997


Product Licensing Framework II


Product Licensing Framework III
September 1998


Cheers ............ murray
Murray_Charters@xxxxxxxxx