June 30, 2008
The Pharmaceutical Past is Prologue
by Peter Pitts
The Wall Street Journal reports that, “Last year, the FDA approved just 19 new medicines, the fewest in 24 years, and announced about 75 new or revised "black-box" warnings about potential side effects -- the agency's strongest -- twice the number in 2004.”
True. But numbers are just numbers. The story is somewhat different when you put those numbers in perspective.
According to the Journal story, “Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, denies that the agency has become "more conservative" about drug safety. Rather, she says, the industry's faltering research efforts are mostly to blame for the fewer product approvals. She says the agency continues to base its decisions on science, not outside pressures. New methods, she adds, have helped it become more vigilant about side effects. She attributed the increase in black-box warnings primarily to a few large groups of medicines that were relabeled."
Reality bites.
Bringing new drugs to market has always been a scientifically challenging and expensive proposition – and it remains so. But the big difference today isn’t (gasp!) politics – it’s that, while discovery and development embrace 21st century science, regulatory science lags behind. At present, the FDA is using 20th century tools to review 21st century medicines.
This is why the agency’s Critical Path Program and the Congressionally-mandated Reagan/Udall Foundation are so crucial to our 21st century healthcare future -- as well as to the future of the pharmaceutical industry.
The comments of Schering-Plough CEO Fred Hassan (courtesy of the Journal article) are instructive:
“Mr. Hassan believes an intensifying focus on safety and a diminished tolerance for side effects at the Food and Drug Administration have dramatically lowered the odds that the drugs would make it to market -- at least not without a lot of extra time and money.”
Not so fast. It is today as it has been in the past and must be in the future – the quest for appropriate risk/benefit balance. Side effects are “tolerated” insofar as the benefits are appropriate. As to the “extra time and money” comment – there’s no benefit from wishing for the “good old days.” Time marches on and so does science. Perhaps a better focus would be on more innovative clinical trial designs – and on the FDA’s promised guidance on adaptive clinical trial designs.
The past is prologue.
"What will it take to get new drugs approved?" Mr. Hassan asks. "The point is, we don't know."
Yes we do. Better development science and better regulatory tools for the FDA.
Posted at 10:06 AM
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June 26, 2008
Repack Attack
by Peter Pitts
pharmaceutical industry in Europe is calling for a ban on the repackaging of medicines within the European Union in order to stamp out the growing threat of counterfeits.
This is not a new idea – but it’s a good one. But it’s often derided as the pharmaceutical industry calling for a policy change for reasons of self-interest rather than public health.
But at the recent BIO convention in San Diego a European Commission representative said that Brussels is seriously considering proposals that would ban repackaging – a move that, if taken would (according to Reuters), “deal a blow to the parallel trade and could also help drugmakers' profits, since companies' revenues are currently eroded by arbitrage dealings in their products across borders.”
Does this mean that the European Commission is in the “pocket of Big Pharma?”
Hardly.
(In fact, it’s humorous considering the way the industry is treated over there.)
What it does mean is that, enfin; the EC is taking seriously what we here at drugwonks.com have been saying for some time – that parallel trade is the weak link in the pharmaceutical chain of custody and a prime target for counterfeit infiltration.
It’s also important to note that what the Europeans call “parallel trade,” we refer to as “importation.” And that Canadian Internet pharmacies get their drugs from Europe. (Note: over 20% of all pharmaceuticals legally sold in the UK are parallel traded into that island nation from other nations within the EU such as Greece, Latvia, Portugal, and Malta and often illegally from places such as Russia and Turkey.
“Safe” importation?
Perhaps in a parallel universe.
Posted at 01:29 PM
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June 23, 2008
Must see TV, eh?
by Peter Pitts
According to PharmaTimes, CanWest Mediaworks, Canada’s largest newspaper publisher and owner of more than 30 television stations, is suing the federal government for not permitting direct-to-consumer advertising of prescription drugs because, it says, this breaches its freedom of expression under Canada’s Charter of Rights and Freedoms.
CanWest is arguing in the Ontario Superior Court that this prohibition, which is part of the Canadian Food and Drugs Act, places it at a competitive disadvantage to US newspaper and magazines which are sold on Canadian newsstands, because it prevents it from selling advertising space to pharmaceutical manufacturers. The company also points out that Canada does allow OTC medicines to be advertised directly to consumers, even though these products also carry risks.
The case will be heard this month.
Posted at 08:18 AM
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June 19, 2008
BIO Break
by Peter Pitts
There’s so much going on at the BIO convention. It’s a healthcare policy feast.
One panel I attended was on the future of personalized medicine via diagnostics. A few of the points made were:
* At present, “trial and error medicine” is the standard of care. Not good for providers, patients, nor payers. That’s true.
* What we today call “personalized medicine” will be referred to in the near future as “medicine.” That’s hopeful.
* Diagnostics will deliver personalized care via drug selection, dosing, efficacy, disease status, recurrence risk, and predisposition. That’s exciting.
* Diagnostics lead the league in the price/value proposition – and that’s what will initially drive uptake. That’s reality.
* To that point, there was also discussion of a diagnostics acceptance continuum beginning with “fear” and then moving to “value” and finally “acceptance.”
* And the constituencies moving along that path include pharmaceutical companies, physicians, patients, payers – and regulators.
* Specifically, to more expeditiously sashay down the Critical Path, the diagnostics industry needs industry-wide guidelines for clinical research.
Take-away is that "personalized" medicine is 21st century medicine. And that's a "win" for physicians, payers ... and even patients. As BIO Chairman (and Vertex CEO) Dr. Joshua Boger commented at the opening day's keynote, we must all be "a confederation of optimists."
Posted at 11:01 AM
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