Latest Drugwonks' Blog
Here's a really superb example of health care grass roots "social marketing" -- made all the more exciting since it bubbled up all by itself ...
http://nocnews.blogspot.com/2007/08/healthcare-prescriptions-and-insurance.html
And in case you cannot link to the Pharmaceutical Executive article mentioned there, here's a better link ...
http://cmpi.org/archives/2007/08/opinion_fewer_cents_more_sense.php
(And, yes, it's the same Nazareth that's in The Band song "The Weight.")
Pulled into Nazareth ...
http://nocnews.blogspot.com/2007/08/healthcare-prescriptions-and-insurance.html
And in case you cannot link to the Pharmaceutical Executive article mentioned there, here's a better link ...
http://cmpi.org/archives/2007/08/opinion_fewer_cents_more_sense.php
(And, yes, it's the same Nazareth that's in The Band song "The Weight.")
Pulled into Nazareth ...
Oh, and the percentage of poor kids without health care coverage, the ones already eligible for Medicaid or SCHIP increased.
So, of course, the solution is to expand government coverage to rich white families.
http://www.census.gov/Press-Release/www/releases/archives/news_conferences/010500.html
So, of course, the solution is to expand government coverage to rich white families.
http://www.census.gov/Press-Release/www/releases/archives/news_conferences/010500.html
Carol Crim is not a name you will read about in the newspapers, although perhaps now you will read her obituary. But no tribute, no matter how well written, could possibly capture the impact this elegant lady had on America's health -- and on me personally.
I knew Carol in her role as executive secretary to Mark McClellan when he was FDA Commissioner. But she had served other Commissioners before him. She represented the Commissioner, the Office of the Commissioner, and the FDA to a wide variety of people both inside and outside of government, regardless of political affiliation, nationality, or degree of scientific standing with something so crucial, yet so lacking in so much of Washington, DC today. Class.
Those who knew her and worked along side her know what I mean. She helped keep us focused, keep our perspective, keep us on schedule and, on many occasions, keep our sanity.
When she became ill her friends and colleagues hoped publicly and wept privately.
Today, we weep publicly.
Carol, thanks for all the small favors, for loyalty and honesty, for precision and professionalism. And thanks for your friendship.
I miss you.
I knew Carol in her role as executive secretary to Mark McClellan when he was FDA Commissioner. But she had served other Commissioners before him. She represented the Commissioner, the Office of the Commissioner, and the FDA to a wide variety of people both inside and outside of government, regardless of political affiliation, nationality, or degree of scientific standing with something so crucial, yet so lacking in so much of Washington, DC today. Class.
Those who knew her and worked along side her know what I mean. She helped keep us focused, keep our perspective, keep us on schedule and, on many occasions, keep our sanity.
When she became ill her friends and colleagues hoped publicly and wept privately.
Today, we weep publicly.
Carol, thanks for all the small favors, for loyalty and honesty, for precision and professionalism. And thanks for your friendship.
I miss you.
along with others in a concise National Review Online symposium..
http://article.nationalreview.com/?q=ZmQwZTIzODQxYWQ3ZDlkNmVlZjVjYzA3MTA3ZTBkNzU=
http://article.nationalreview.com/?q=ZmQwZTIzODQxYWQ3ZDlkNmVlZjVjYzA3MTA3ZTBkNzU=
Not really, but Drew Altman of the Kaiser Family Foundation inadvertently comes up with great idea in plugging KFF's latest waste of money.
On the heels of co-sponsoring the hard hitting survey showing that poor seniors without Medicare part D coverage paid more for drugs than those without, KFF spent part of it's billions ona poll examining just how many people were affected by "Sicko."
Turns out that less than 4 percent of Americans saw the movie, give or take a couple of percentage points (that includes folks who saw it on the Web for free). Needless to say that's not the story KFF wanted to tell. So it asked who had heard of Michael Moore and Sicko right after the both had been basted with a huge marketing blitz. (Ok to market Sicko but not drugs, right?)
"The new poll finds that almost half (46%) had seen the movie or heard or read something about it a little over a month after its national release. This is not much less than the share of adults (61%) who were aware of "An Inconvenient Truth," the documentary on climate change featuring former Vice President Al Gore released in May 2006."
Well, at least Gore can say he won that race.
So what's the precious dross we can take away from this KFF poll?
"Our poll shows how the combination of good timing, a controversial director, and lots of free media attention can generate real impact for a film that very few people have actually seen," said Kaiser President and CEO Drew E. Altman, Ph.D. "'Sicko' is not a commercial juggernaut like 'Transformers' or 'Harry Potter,' and we're not likely to find Michael Moore action figures at fast food restaurants any time soon. But we are starting to see how films about social issues that capitalize on free media rather than traditional marketing can become social phenomena too."
A Michael Moore action figure at a fast food restaurant. Now THAT is funny. Maybe KFF would also be interested in my concept for a health care action movie. It would start Bruce Willis as a NYPD type in London who rescues Michael Moore when is taken hostage by a NHS doctor who is also a terrorist. It's called Fat Free or Die Hard.
PS Does a KFF poll promoting "Sicko" count as 'free media' or 'traditional marketing?'
On the heels of co-sponsoring the hard hitting survey showing that poor seniors without Medicare part D coverage paid more for drugs than those without, KFF spent part of it's billions ona poll examining just how many people were affected by "Sicko."
Turns out that less than 4 percent of Americans saw the movie, give or take a couple of percentage points (that includes folks who saw it on the Web for free). Needless to say that's not the story KFF wanted to tell. So it asked who had heard of Michael Moore and Sicko right after the both had been basted with a huge marketing blitz. (Ok to market Sicko but not drugs, right?)
"The new poll finds that almost half (46%) had seen the movie or heard or read something about it a little over a month after its national release. This is not much less than the share of adults (61%) who were aware of "An Inconvenient Truth," the documentary on climate change featuring former Vice President Al Gore released in May 2006."
Well, at least Gore can say he won that race.
So what's the precious dross we can take away from this KFF poll?
"Our poll shows how the combination of good timing, a controversial director, and lots of free media attention can generate real impact for a film that very few people have actually seen," said Kaiser President and CEO Drew E. Altman, Ph.D. "'Sicko' is not a commercial juggernaut like 'Transformers' or 'Harry Potter,' and we're not likely to find Michael Moore action figures at fast food restaurants any time soon. But we are starting to see how films about social issues that capitalize on free media rather than traditional marketing can become social phenomena too."
A Michael Moore action figure at a fast food restaurant. Now THAT is funny. Maybe KFF would also be interested in my concept for a health care action movie. It would start Bruce Willis as a NYPD type in London who rescues Michael Moore when is taken hostage by a NHS doctor who is also a terrorist. It's called Fat Free or Die Hard.
PS Does a KFF poll promoting "Sicko" count as 'free media' or 'traditional marketing?'
Guarantees are hard to come by. Even with medicine, doctors would be hard-pressed to tell patients that the drug they're prescribing is certain to work. After all, thanks to different medical histories, personal biochemistries, and physiologies, everyone is different. There's no such thing as a "me-too" patient.
That's why patients and their doctors often try a variety of different drugs before finding one that works - because there's no such thing as a "me-too" medicine. But in the interest of saving a few bucks, such personalized treatments may soon become a thing of the past.
This fundamental misunderstanding is being advanced by politicians grasping for answers to questions on health care. For an example, look no further than Reps. Tom Allen, D-ME, and Jo Ann Emerson, R-MO, whose Enhanced Health Care Value for All Act would increase spending on one-size-fits-all, top-down solutions.
The bill would authorize $3 billion of investment on new research "on the comparative effectiveness of health care services (including prescription drugs, medical devices, procedures, and other treatments) to inform health care providers' decisions." Senator Hillary Clinton also has advocated a similar program.
Here's the rest of the story, courtesy of the Tampa Tribune ...
http://www2.tbo.com/content/2007/aug/27/na-one-size-medicine-does-not-fit-all/?news-opinion-commentary
Comparative Effectiveness -- the Hanging Chad of Health Care
That's why patients and their doctors often try a variety of different drugs before finding one that works - because there's no such thing as a "me-too" medicine. But in the interest of saving a few bucks, such personalized treatments may soon become a thing of the past.
This fundamental misunderstanding is being advanced by politicians grasping for answers to questions on health care. For an example, look no further than Reps. Tom Allen, D-ME, and Jo Ann Emerson, R-MO, whose Enhanced Health Care Value for All Act would increase spending on one-size-fits-all, top-down solutions.
The bill would authorize $3 billion of investment on new research "on the comparative effectiveness of health care services (including prescription drugs, medical devices, procedures, and other treatments) to inform health care providers' decisions." Senator Hillary Clinton also has advocated a similar program.
Here's the rest of the story, courtesy of the Tampa Tribune ...
http://www2.tbo.com/content/2007/aug/27/na-one-size-medicine-does-not-fit-all/?news-opinion-commentary
Comparative Effectiveness -- the Hanging Chad of Health Care
Commentary from today's edition of The Wall Street Journal ...
Patent Remedy
By RONALD A. CASS
The European Union's trade commissioner, Peter Mandelson, recently joined the U.S. in protesting Thailand's effective theft of pharmaceutical companies' intellectual property. Despite efforts of health activists to portray the world community as accepting -- even endorsing -- Thailand's conduct, there is growing appreciation that trampling patents to allow a middle-income nation to cut its spending on drugs seriously threatens the world's system of protections for innovation.
The basic issues are relatively simple. Improvements in the way we treat diseases, communicate, store information and do so much else depend on innovation. To encourage innovators, laws give them the right to control the uses of their inventions for a period of time, to decide who makes products using their innovations, and to set the price for access to this "intellectual property."
The World Trade Organization's agreement on Trade-Related Aspects of Intellectual Property Rights (Trips) ties other trade rights to adequate respect for partners' patents, copyrights and trademarks. Compulsory licensing -- forcing patent owners to allow others to manufacture products using their innovations at prices set by the government -- is permitted under extraordinary conditions, such as when a critical patent is not being used to produce essential goods. This has always been understood as limited to a small set of special cases.
While the system of IP protections has worked well to encourage investment in innovations, some groups oppose protection of all property rights. Over the past decade, these groups have worked hard to alter the meaning of the Trips agreement and to encourage governments to use compulsory licensing to break IP protections.
These groups gained a small victory when the WTO said in 2001 that Trips encompassed "flexibilities" -- including compulsory licensing -- that allow governments to deal with health emergencies such as might be posed by epidemics of tuberculosis, malaria or HIV/AIDS in sub-Saharan Africa. WTO ministers agreed as well that there was not a single definition for all nations at all times of what constitutes an appropriate sort of emergency to justify compulsory licensing.
The activists used that declaration to argue that Trips authorizes any nation to impose compulsory licensing on any patent, especially any drug patent, for any reason. The military-backed Thai government's compulsory licensing initiative, pushed by its Public Health Ministry, is the first fruit of the activists' campaign -- a relatively developed nation facing no epidemic, just seeking to shift its spending priorities by taking someone else's property.
The U.S. clearly signaled its view that this works a radical change in the legal system for protecting IP. It put Thailand on the Priority Watch list for nations violating IP rights and formally protested Thailand's action. These moves could lead to trade sanctions on Thailand.
The EU's letter, adding Europe's voice, is especially interesting given the attacks that Neelie Kroes, the EU's competition minister, has launched on IP rights. While Ms. Kroes blithely assumes that her assertion of control over the uses and prices of IP created by firms like Microsoft won't harm innovation, Mr. Mandelson recognizes that any government's assault on the system of IP protections can unravel a thread that supports an increasing proportion of the global economy.
Having set the stage for a potentially disastrous turn in world protection of IP rights, Thailand has a chance to show leadership in a very different way. If its prime minister reins in its Public Health Ministry, Thailand can remind those in Europe and the U.S. who waver on protection for IP rights that the costs of undermining innovation vastly exceed short-term gains from cutting prices on patented drugs. Protecting the benefits from innovation and trade should matter more than pleasing the activists -- no matter how loudly they complain.
Mr. Cass is chairman of the Center for the Rule of Law, dean emeritus of Boston University School of Law and former vice chairman of the U.S. International Trade Commission.
Patent Remedy
By RONALD A. CASS
The European Union's trade commissioner, Peter Mandelson, recently joined the U.S. in protesting Thailand's effective theft of pharmaceutical companies' intellectual property. Despite efforts of health activists to portray the world community as accepting -- even endorsing -- Thailand's conduct, there is growing appreciation that trampling patents to allow a middle-income nation to cut its spending on drugs seriously threatens the world's system of protections for innovation.
The basic issues are relatively simple. Improvements in the way we treat diseases, communicate, store information and do so much else depend on innovation. To encourage innovators, laws give them the right to control the uses of their inventions for a period of time, to decide who makes products using their innovations, and to set the price for access to this "intellectual property."
The World Trade Organization's agreement on Trade-Related Aspects of Intellectual Property Rights (Trips) ties other trade rights to adequate respect for partners' patents, copyrights and trademarks. Compulsory licensing -- forcing patent owners to allow others to manufacture products using their innovations at prices set by the government -- is permitted under extraordinary conditions, such as when a critical patent is not being used to produce essential goods. This has always been understood as limited to a small set of special cases.
While the system of IP protections has worked well to encourage investment in innovations, some groups oppose protection of all property rights. Over the past decade, these groups have worked hard to alter the meaning of the Trips agreement and to encourage governments to use compulsory licensing to break IP protections.
These groups gained a small victory when the WTO said in 2001 that Trips encompassed "flexibilities" -- including compulsory licensing -- that allow governments to deal with health emergencies such as might be posed by epidemics of tuberculosis, malaria or HIV/AIDS in sub-Saharan Africa. WTO ministers agreed as well that there was not a single definition for all nations at all times of what constitutes an appropriate sort of emergency to justify compulsory licensing.
The activists used that declaration to argue that Trips authorizes any nation to impose compulsory licensing on any patent, especially any drug patent, for any reason. The military-backed Thai government's compulsory licensing initiative, pushed by its Public Health Ministry, is the first fruit of the activists' campaign -- a relatively developed nation facing no epidemic, just seeking to shift its spending priorities by taking someone else's property.
The U.S. clearly signaled its view that this works a radical change in the legal system for protecting IP. It put Thailand on the Priority Watch list for nations violating IP rights and formally protested Thailand's action. These moves could lead to trade sanctions on Thailand.
The EU's letter, adding Europe's voice, is especially interesting given the attacks that Neelie Kroes, the EU's competition minister, has launched on IP rights. While Ms. Kroes blithely assumes that her assertion of control over the uses and prices of IP created by firms like Microsoft won't harm innovation, Mr. Mandelson recognizes that any government's assault on the system of IP protections can unravel a thread that supports an increasing proportion of the global economy.
Having set the stage for a potentially disastrous turn in world protection of IP rights, Thailand has a chance to show leadership in a very different way. If its prime minister reins in its Public Health Ministry, Thailand can remind those in Europe and the U.S. who waver on protection for IP rights that the costs of undermining innovation vastly exceed short-term gains from cutting prices on patented drugs. Protecting the benefits from innovation and trade should matter more than pleasing the activists -- no matter how loudly they complain.
Mr. Cass is chairman of the Center for the Rule of Law, dean emeritus of Boston University School of Law and former vice chairman of the U.S. International Trade Commission.
This one showing that poor seniors who don't enroll in part D are more likely to have higher out of pocket costs than seniors that do enroll.
Imagine the brainpower it took to come to that conclusion.
Next study from Commonwealth: People with insurance have more coverage than people who don't have insurance.
Oh the humanity.
http://www.kff.org/medicare/med082107nr.cfm
Imagine the brainpower it took to come to that conclusion.
Next study from Commonwealth: People with insurance have more coverage than people who don't have insurance.
Oh the humanity.
http://www.kff.org/medicare/med082107nr.cfm
Info via the Pink Sheet (in plain text) with comments (in bold) courtesy of drugwonks.com.
German Health Reform Law Could Shake Up Pharmaceutical Market
Drug companies in the United States and Europe are warily watching a new law in Germany that could change the competitive landscape.
Sure it'll hit their pocketbooks -- but the folks who will really get screwed are patients and physicians.
The legislation - The Act for the Enhancement of Competition in Statutory Health Insurance - includes several provisions aimed at reducing drug costs. Most significantly, the measure requires that cost-benefit analyses be performed on certain drugs, the results of which will be used to set reimbursement ceilings. Drug companies are mainly worried about how these analyses will be conducted.
Worried, but not wondering, because the studies that will be used are the studies that are already being used -- RCTs that were neither designed nor intended to be used for comparative effectiveness purposes.
Other provisions also could change the market. The law, which came into effect in April, requires consumers to obtain a second opinion from a physician to receive prescriptions for drugs that are expensive or have significant risks, and it allows health insurance funds to set up biddings between drug manufacturers with the aim of establishing rebate contracts.
Does this mean a second opinion from the first doc, or does the patient have to seek out and consult with an additional physician? If the former, where's the hammer, if the latter, it's just the latest move to disempower physicians from the appropriate practice of medicine as they see fit.
The GBA (or Joint Federal Committee of Physicians, Dentists, Hospitals and Health Insurance Funds) is responsible for determining which drugs will be subject to reimbursement. Since 2004, it has directed the Institute for Quality and Economy in the Health Care System (IQWiG) to conduct drug benefit analyses. Under the new law, it now will ask the institute to perform cost-benefit analyses for certain drugs. If the IQWiG finds there is an advantage for patients to use a drug, the GBA will allow its reimbursement.
But "advantage" is in the eye of the government, aka "the payor." So, just whose "advantage" do you think takes precedence?
"The idea is to ban all drugs from reimbursement which are more expensive than others but do not have a therapeutic advance," said Ralf-Thomas Hillebrand, a spokesperson for the German Association of Research-Based Pharmaceutical Companies (VFA).
How do you say "incremental innovation" in German?
Drugs that are therapeutically superior to other medicines are not subject to reference pricing.
I'm sure that looks terrific on paper -- as did Mr. Chamberlain's infamous "piece of paper" -- but what percent of medicines do you think are subject to reference pricing in Germany? This is nothing more than health care appeasement -- "health care savings in our time."
The legislation is the latest in a string of German reforms intended to rein in drug costs and bolster the country's public statutory health insurance system - the SHI - which covers about 90 percent of the population. The system is funded through wage deductions.
You mean it's not ... free?
German Health Reform Law Could Shake Up Pharmaceutical Market
Drug companies in the United States and Europe are warily watching a new law in Germany that could change the competitive landscape.
Sure it'll hit their pocketbooks -- but the folks who will really get screwed are patients and physicians.
The legislation - The Act for the Enhancement of Competition in Statutory Health Insurance - includes several provisions aimed at reducing drug costs. Most significantly, the measure requires that cost-benefit analyses be performed on certain drugs, the results of which will be used to set reimbursement ceilings. Drug companies are mainly worried about how these analyses will be conducted.
Worried, but not wondering, because the studies that will be used are the studies that are already being used -- RCTs that were neither designed nor intended to be used for comparative effectiveness purposes.
Other provisions also could change the market. The law, which came into effect in April, requires consumers to obtain a second opinion from a physician to receive prescriptions for drugs that are expensive or have significant risks, and it allows health insurance funds to set up biddings between drug manufacturers with the aim of establishing rebate contracts.
Does this mean a second opinion from the first doc, or does the patient have to seek out and consult with an additional physician? If the former, where's the hammer, if the latter, it's just the latest move to disempower physicians from the appropriate practice of medicine as they see fit.
The GBA (or Joint Federal Committee of Physicians, Dentists, Hospitals and Health Insurance Funds) is responsible for determining which drugs will be subject to reimbursement. Since 2004, it has directed the Institute for Quality and Economy in the Health Care System (IQWiG) to conduct drug benefit analyses. Under the new law, it now will ask the institute to perform cost-benefit analyses for certain drugs. If the IQWiG finds there is an advantage for patients to use a drug, the GBA will allow its reimbursement.
But "advantage" is in the eye of the government, aka "the payor." So, just whose "advantage" do you think takes precedence?
"The idea is to ban all drugs from reimbursement which are more expensive than others but do not have a therapeutic advance," said Ralf-Thomas Hillebrand, a spokesperson for the German Association of Research-Based Pharmaceutical Companies (VFA).
How do you say "incremental innovation" in German?
Drugs that are therapeutically superior to other medicines are not subject to reference pricing.
I'm sure that looks terrific on paper -- as did Mr. Chamberlain's infamous "piece of paper" -- but what percent of medicines do you think are subject to reference pricing in Germany? This is nothing more than health care appeasement -- "health care savings in our time."
The legislation is the latest in a string of German reforms intended to rein in drug costs and bolster the country's public statutory health insurance system - the SHI - which covers about 90 percent of the population. The system is funded through wage deductions.
You mean it's not ... free?
Drug Industry Daily
Aug. 27, 2007 | Vol. 6 No. 168
PDUFA Provisions Could Harm FDA and Industry, Expert Say
Some of the provisions in the FDA Revitalization Act, S. 1082 and H.R. 2900, would be ineffective, could cripple the FDA and would put unnecessary burdens on pharmaceutical companies, Center for Medicine in the Public Interest President Peter Pitts said at the Third Annual FDA Regulatory and Compliance Symposium at Harvard University. “Political battles are trumping public health,†he added.
The most important part of the bill is a provision funding the Reagan-Udall Institute and the agency’s Critical Path Initiative, according to Pitts. “This is the single most important advance and change in FDA legislation, possibly ever,†he said. “It really sets the FDA on the path to a 21st century perspective in terms of both protecting the public health and advancing the public health.â€
The FDA’s recent label change for Coumadin (warfarin) to add information about genetic tests was “such an important advance,†Pitts said, adding that the agency should continue doing more with the Critical Path Initiative (DID, Aug. 17).
However, Pitts said some provisions in the legislation will be ineffective and could harm the FDA. He criticized a provision that would ban members with more than $50,000 in financial conflicts of interest from voting on advisory committees. The FDA recently issued a draft guidance of a proposed rule that would do the same thing (DID, March 22).
“All this will succeed in doing is allow the agency to recruit the second best and the almost brightest for advisory committees, and that is not acceptable,†Pitts said. He added that $50,000 is an arbitrary limit.
Pitts also criticized the bill’s Risk Evaluation and Mitigation Strategies (REMS) requirements. He noted that early drafts of the bill contained language that would have made it mandatory for each new drug application to contain an REMS. “That’s like saying every new product is equally risky,†Pitts said.
Giving the FDA the authority to require an REMS as part of a new drug application could encourage the agency to call for them more, even when they are unnecessary, he said.
However, the enhanced focus on safety and postmarketing surveillance is the industry’s fault for not living up to its commitments to conduct postmarketing studies, Pitts said. “Now they are reaping what they sowed,†he added. Companies should use the opportunity to conduct postmarketing studies for public health purposes, he said.
Pitts also criticized the provisions in the bill that would add a user fee for a voluntary review of direct-to-consumer advertisements. The FDA’s Division of Drug Marketing, Advertising and Communications has no predictability and will send companies warning letters even if they incorporated all of the agency’s suggestions in their advertisements, according to Pitts. “If the FDA wants to have an impact in quality and safety and appropriateness, they can’t change their minds after the fact, fee or no fee.†— Emily Ethridge
Aug. 27, 2007 | Vol. 6 No. 168
PDUFA Provisions Could Harm FDA and Industry, Expert Say
Some of the provisions in the FDA Revitalization Act, S. 1082 and H.R. 2900, would be ineffective, could cripple the FDA and would put unnecessary burdens on pharmaceutical companies, Center for Medicine in the Public Interest President Peter Pitts said at the Third Annual FDA Regulatory and Compliance Symposium at Harvard University. “Political battles are trumping public health,†he added.
The most important part of the bill is a provision funding the Reagan-Udall Institute and the agency’s Critical Path Initiative, according to Pitts. “This is the single most important advance and change in FDA legislation, possibly ever,†he said. “It really sets the FDA on the path to a 21st century perspective in terms of both protecting the public health and advancing the public health.â€
The FDA’s recent label change for Coumadin (warfarin) to add information about genetic tests was “such an important advance,†Pitts said, adding that the agency should continue doing more with the Critical Path Initiative (DID, Aug. 17).
However, Pitts said some provisions in the legislation will be ineffective and could harm the FDA. He criticized a provision that would ban members with more than $50,000 in financial conflicts of interest from voting on advisory committees. The FDA recently issued a draft guidance of a proposed rule that would do the same thing (DID, March 22).
“All this will succeed in doing is allow the agency to recruit the second best and the almost brightest for advisory committees, and that is not acceptable,†Pitts said. He added that $50,000 is an arbitrary limit.
Pitts also criticized the bill’s Risk Evaluation and Mitigation Strategies (REMS) requirements. He noted that early drafts of the bill contained language that would have made it mandatory for each new drug application to contain an REMS. “That’s like saying every new product is equally risky,†Pitts said.
Giving the FDA the authority to require an REMS as part of a new drug application could encourage the agency to call for them more, even when they are unnecessary, he said.
However, the enhanced focus on safety and postmarketing surveillance is the industry’s fault for not living up to its commitments to conduct postmarketing studies, Pitts said. “Now they are reaping what they sowed,†he added. Companies should use the opportunity to conduct postmarketing studies for public health purposes, he said.
Pitts also criticized the provisions in the bill that would add a user fee for a voluntary review of direct-to-consumer advertisements. The FDA’s Division of Drug Marketing, Advertising and Communications has no predictability and will send companies warning letters even if they incorporated all of the agency’s suggestions in their advertisements, according to Pitts. “If the FDA wants to have an impact in quality and safety and appropriateness, they can’t change their minds after the fact, fee or no fee.†— Emily Ethridge
Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.
