May 09, 2008
Tribulations and Trials
by Peter Pitts
According to David Lepay, the FDA's senior advisor for clinical science, the agency and the HHS Office for Human Research Protections are working on a final rule for registering institutional review boards (IRBs), the first of the FDA’s efforts to issue regulations instead of guidances for clinical trials.
Existing FDA regulations do not take into account all the different types of organizations — vendors, co-investigators, site management organizations and contract research organizations — involved in conducting clinical trials.
FDA regulations fail to account for electronic data issues, data standardization, electronic health records, electronic patient-reported outcomes and electronic case report forms. “We are working with groups within and outside the FDA to address this,” Lepay said at the annual conference of the Association of Clinical Research Professionals.
The FDA also is working to improve its internal processes to address “why it takes so long to disqualify clinical investigators” caught in wrongdoing, Lepay said. Recently, U.S. Reps. Joe Barton (R-Texas) and John Shimkus (R-Ill.) asked the Government Accountability Office to examine why the agency has been so slow to discipline investigators.
It's not a question of doing it fast. It's a question of doing it right.
Posted by peterpitts at 09:25 AM
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April 11, 2008
Congress Gets Tough on ... Drug Importation?
by Peter Pitts
According to Congressional Quarterly, Chairman Dingell is aggressively pursuing efforts to require the FDA to take a much more aggressive role in monitoring food and drug production and safety abroad, with stiff penalties for companies that import tainted products. The article says: “Dingell’s plan would also crack down on companies that violate drug import regulations. Manufacturers and importers could be fined as much as $500,000 for bringing contaminated or adulterated food or drugs into the country, and individuals could be subject to fines as high as $100,000 for similar offenses.”
You may ask, How is that statement compatible with legislators’ calls for liberalized prescription drug importation? Good question.
Hopefully Mr. Dingell will point this out when his colleagues raise the subject.
Posted by peterpitts at 11:05 AM
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February 19, 2008
Importation a "done deal? Don't bet on it.
by Peter Pitts
Like they say, everything you read in the newspaper is true – except for those things you know about personally.
Case in point: the Wall Street Journal reporting that, regardless of which of the remaining three amigos gets elected in November, “drugs from Canada” is a done deal.
Nope. Here’s why not:
(1) It won’t save any money. Let’s not forget the non-partisan CBO study that showed that such policy would reduce our nation’s spending on prescription medicines a whopping 0.1% -- and that’s not including the millions of dollars the FDA would need to set up a monitoring system.
(2) The drugs being sent to U.S. customers from Canadian internet pharmacies are not “the same drugs Canadians get.” That bit of rhetoric is just plain wrong. Canadian internet pharmacies – by their own admission – are sourcing their drugs from the European Union. And while they may say their drugs come from the United Kingdom, let’s not conveniently forget that 20% of all the medicines sold in the UK are parallel imported from other nations in the EU – like Spain, Greece, Portugal, and Lithuania.
And the important political point here is that when Americans are asked if they want drugs from nations other than Canada – the answer is a resounding “no thank you.”
(3) The state experience has been dismal and politically embarrassing. Remember the high profile “I-Save-RX”program? Over 19 months of operation, a grand total of 3,689 Illinois residents used the program -- which equals approximately .02% of the population. They don’t call him “Wrong Way” Rod Blagojevich for nothing.
And what of Minnesota and Governor Tim Pawlenty’s RxConnect program? According to its latest statistics, Minnesota RxConnect fills about 138 prescriptions a month. That's for the whole state. Minnesota population: 5,167,101.
And remember Springfield, MA and “the New Boston Tea Party?” Well the city of Springfield is now out of the drugs from Canada business.
(4) National Security concerns. According to a recent report from the federal Joint Terrorism Task Force, a global terrorist ring with ties to Hezbollah, is importing counterfeit drugs into America by way of Canada. They are doing so for profit today - but could just as easily do so for more nefarious and deadly purposes. And legalizing importation would only facilitate such actions.
So while the candidates may opt for “drugs from Canada” as a useful political talking point – a way to say “look how tough I can be on those bad drug companies. The real issue lies elsewhere.
When it comes to health care reform, there’s one major policy difference that sets Senator McCain apart from Senators Obama and Clinton – Senator McCain believes in the strengths of a market economy. He sees drug importation as an access issue. The other side sees it as a way to import price controls and a first step towards government-run health care.
Don’t get fooled by the importation rhetoric. It’s nothing but a side-show. And it ain’t gonna happen. It's more dangerous as a smoke screen.
Posted by peterpitts at 08:10 AM
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June 27, 2007
Lies. Damn Lies. And Drug Importation
by Peter Pitts
Just because you say it enough times doesn't make it true.
Most recent example that proves this maxim is the attempt by certain members of Congress -- in this case U.S. Representatives Rahm Emanuel (D-IL), Jo Ann Emerson (R-MO), Rosa DeLauro (D-CT), and Marion Berry (D-AR) -- to hide the facts that drug importation is neither safe nor smart.
The Fearsome Four offer the following reasons why drug importation is a good idea. (We offer the facts in bold -- because the truth must be told boldly.)
The Fearsome Four claim that the same brand name drugs cost 35-55% less in other nations then they do in the US.
That's because the nation's of the EU (and Canada) have price controls that equal choice controls for their citizens. Also, the rest of the world unfairly shirks its responsibilities to shoulder their fair share of the burden of research and development. This is what members of Congress should be up in arms about.
The Fearsome Four say that drug importation has been in place in the European Union (where they call it "parallel trade") for more than 20 years with no safety problems.
Believe it or not, their "source" for this is Peter Rost. For the truth I prefer the European Commission who has identified parallel trade as the weak link in the chain for counterfeiters. It's also convenient (although not responsible) to forget that the British regulatory authorities have recently found counterfeit and substandard medicines in their island kingdom -- courtesy of parallel trade.
The Fearsome Four claim the pharmaceutical industry has imported drugs and sold them in the U.S. for decades. In fact, 40 percent of the drugs consumed by Americans today are made in foreign manufacturing plants.
That's right -- in plants authorized and inspected by the FDA. The Four conveniently omit the fact that their legislation would allow in medicines from plants not approved by the FDA. Oops.
The Fearsome Four claim that prescription drug importation will result in $50 billion in direct savings alone over the next decade, a $10 billion benefit to the federal budget.
For this fact they cite a Congressional Budget Office Study. But what the study actually says is that such a program woyuld reduce the drug spend in the US by .01%. And that doesn't include the monies needed to set up an entirely new, international system for drug regulation.
And finally, the Fearsome Four claim that passage of the Pharmaceutical Market Access and Drug Safety Act will finally assure the security of our drug supply.
Assure the safety of our drug supply? This is the biggest whopper of them all. How will our domestic medicines supply be "safer" when we open our borders to drugs from Estonia, Latvia, Malta, Greece, and Portugal -- to name only a few. Because what the Fearsome Four aren't saying is that "drugs from the United Kingdom" means drugs from all of the 27 EU nations -- many of which have had their own supply chains infiltrated by counterfeits from Russia and elsewhere. They should do their homework.
What happens when pesky facts get in the way of political grandstanding?
Good things
Posted by peterpitts at 03:18 PM
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March 19, 2007
The Side Effects of Side Effects
by Peter Pitts
Here's an interesting article from Medical Marketing & Media, with many good interviews (Dan Troy, Scott Gottlieb, Steve Galson, Andy von Eschenbach, Dan Carpenter, Sheila Burke, etc.), on the timely question, Wither PDUFA?
Voila la link ...
Worth a look.
Posted by peterpitts at 08:37 AM
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October 13, 2006
Is Hezbollah Filling Your Prescription
by Peter Pitts
I've penned a new op-ed running in today's edition of the San Diego Union-Tribune on the issue that won't go away -- drug importation. Even though it says it's authored by Leonard Pitts, it's actually written by yours truly (note citation at the end of the article). We rarely get confused in person.
Click on this link and then go to "Today's Paper" and then to "Opinion."
http://www.signonsandiego.com
Have a look and spread the word that we must transcend the soundbites about drug importation.
Posted by Peter Pitts at 10:46 AM
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August 23, 2006
Charge it? Nope.
by Peter Pitts
Plastics.
It was good advice in “The Graduate,” but it’s bad news for internet profiteers masquerading as pharmacists.
Both Visa and MasterCard rules prohibit the processing of any illegal transactions such as those from illegal online pharmacies. Both card companies have issued fines for doing so. Several online pharmacy accounts, in fact, were recently terminated as a result of card Association and member bank pressure.
To do business with online pharmacies it is required that the member bank conduct an investigation for every online pharmacy. This will include providing a copy of the pharmacy’s license, a statement that the merchant’s sales activity is in compliance with all applicable laws, proof that valid prescriptions are required before medications are dispensed and proof that only prescriptions from licensed physicians are accepted.
Any questions?
Posted by Peter Pitts at 10:58 AM
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August 22, 2006
The Cost of International Drug Piracy In California
by Peter Pitts
Professor Philip Romero of the University of Oregon, and economic advisor to former California Governor Pete Wilson, has issued a damning report on the negative welfare consequences of normalizing the illegal diversion of prescription drugs into the U.S., as recently proposed by Governor Schwarzenegger. Basically, stripping away drug makers’ rights to enjoy the fruits of their own invention will deestroy investors’ willingness to risk their capital in California’s biotech industry. Up to 100,000 biotech jobs will be lost in the Golden State and $3 billion in economic growth. That’s a heck of a price to pay for a policy that won’t even result in lower-priced drugs in the long term!
Posted by Peter Pitts at 09:32 AM
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