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The pilot scheme involves 25 pharmacies in the Stockholm area. Pharmacists will be scanning about 110,000 pharmaceutical packs that have a special two-dimensional barcode (similar to those found on airline boarding passes) using a scanning device at the point of dispensing.
The scanned product would be checked against the manufacturer's records in a central database to verify whether it is genuine, as the product would have a unique serial number. The data matrix would be enough to individually code each medicine pack with information including a product code, batch number, expiry date and a unique serial number.
The system has proven to be a cheaper and easier solution to implement than other authentication schemes such as track and trace and RFID tagging, believes EFPIA. It also offers advantages such as reducing dispensing errors and reimbursement fraud.
Heinz Kobelt, secretary general of the European parallel traders association, the EAEPC, is concerned about who is "master of the data" in the central database. "If pharmaceutical manufacturers get free access to the data, they can use it against parallel traders. We need an independent agency to run the central database."
Colin Mackay, EFPIA's spokesperson, told Scrip that it was uncertain who would fund the scheme if it were rolled out across Europe, but financers should include all stakeholders, including the pharmaceutical industry, wholesalers, pharmacists, parallel traders and member states.
The EFPIA system is being piloted in collaboration with the European wholesaler trade association, GIRP, and local Swedish full-line wholesalers Tamro and Kronans Droghandel. EFPIA has said that accredited full-line wholesalers would be able to access the database to check the status of the product at any time.
The European Parliament's Committee on the Environment, Public Health and Food Safety is expected to issue a report on the Commission's counterfeiting proposals next month. EFPIA plans to issue the results of the completed pilot early next year.
What about the other nine years?
That, it seems, is the purview of S.1776 and, according to the New York Times, “Congressional Democrats have no plans to offset the cost of S. 1776, which is why they are eager to keep it separate from the broader health care legislation and avoid breaking the president’s promise.”
That promise again, “I will not sign a plan that adds one dime to our deficits — either now or in the future. Period.”
Well, it seems that many in Congress are looking at the “period” and seeing an ellipse.
The Times continues, “Congressional Democrats insist that fixing the doctor payment formula should not count toward the cost of the big health care legislation, because it is a problem they inherited.”
Unlike the problem of the uninsured? Unlike the problem of preexisting conditions? Unlike the problem of the donut hole? Unlike the problem of (FILL IN THE BLANK)?
Sounds like a total ellipse of the sum.
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Galen Institute Releases Poll Showing Overwhelming Opposition to the Individual Mandate and Other Key Components of Congressional Health Reform Proposals
Seventy-one Percent Are Concerned Their Health Insurance Will
Change if Congress Passes Health Reform Legislation
For more information, please contact:
Jeff Lungren, Communications Director
(703) 299-9207 or jeff@galen.org
ALEXANDRIA, VA. OCTOBER 19, 2009 – The Galen Institute today released new survey results showing overwhelming opposition to the individual mandate and other key components of health reform legislation Congress is considering.
“These findings illustrate strong opposition to fundamental aspects of the bills moving through Congress,” said Galen Institute President Grace-Marie Turner. “People don’t want to be forced to buy insurance they can’t afford or that might not fit their needs, yet the proposals would slap a tax on them if they don’t. And people overwhelmingly oppose reducing seniors’ health benefits or raising taxes on the working and middle class in order to expand coverage to some of the uninsured, yet many in Congress continue to push exactly that.”
“What the public does favor is a targeted approach to solving problems in our health sector, but not a complete Washington-style overhaul of one-sixth of our economy. Washington’s failure to listen is causing great apprehension and concern among the public,” added Turner.
The nationwide random survey of 510 adults was conducted October 8-11, 2009 and has a +/- 4.34 margin of error. International Communications Research (ICR), a non-partisan research firm based in Pennsylvania, conducted the survey.
More Than Seven in Ten Oppose the Individual Mandate
Seventy-one percent of those surveyed said they would oppose “a new law saying that everyone either would have to obtain private or public health insurance approved by the government or pay a tax of $750 or more every year.” Only 21 percent said they would support the law. More than half (54 percent) of all respondents indicate a “strong” opposition to the individual mandate, including 58 percent of those 45-54 years of age and 58 percent of those 55 years and older.
More Than Two-Thirds Oppose Reducing Seniors’ Health Benefits to Pay for Covering the Uninsured
More than two-thirds (68 percent) oppose reducing “some health insurance benefits for senior citizens in order to expand health insurance for some people who are uninsured,” while 28 percent support the idea. Opposition is spread across political party lines as 86 percent of Republicans, 66 percent of Independents, and 59 percent of Democrats oppose this idea.
Opposition to Raising Taxes on the Working and Middle Class to Cover the Uninsured
Fifty-eight percent disagree, most of them “strongly” (44 percent), with the following statement: “I would support an increase in taxes on the working and middle class if it would help provide health insurance to more Americans.” Only 39 percent support the position.
Seventy-one Percent Are Concerned Current Health Insurance Will Change if Congress Passes Health Reform
Seventy-one percent said they were concerned that their current health insurance would change if Congress passes health reform legislation. One-quarter (25 percent) said they were not concerned. Groups with the highest level of concern include: people 55 years and older (84 percent), those aged 45-54 (80 percent), Republicans (82 percent), and Independents (78 percent). Almost half (47 percent) of all respondents indicate they are “very concerned.” Sixty-two percent of people aged 55 years and older are “very concerned,” along with 61 percent of Republicans, 63 percent of those in the South, and 54 percent of Independents.
Support for a Targeted Approach to Addressing Health Care
Forty-nine percent support, “A targeted approach that addresses a few problems at a time.” Forty-one percent support, “A comprehensive approach that makes significant changes to our current health care system.”
_________________________________
Here are Details of the Survey’s Results
Question: Let's say that Congress passed a new law saying that everyone either would have to obtain private or public health insurance approved by the government or pay a tax of $750 or more every year. Would you support or oppose this law?
STRONGLY SUPPORT 13%
SOMEWHAT SUPPORT 8%
SOMEWHAT OPPOSE 17%
STRONGLY OPPOSE 54%
DON’T KNOW/REFUSED 8%
Question: Which of the following approaches to health care reform do you favor?
A comprehensive approach that
makes significant changes to our 41%
current health care system?
A targeted approach that
addresses a few problems at a time? 49%
NEITHER 4%
DON’T KNOW 5%
Question: Do you agree or disagree with the following statement? "I would support an increase in taxes on the working and middle class if it would help provide health insurance to more Americans."
STRONGLY AGREE 18%
SOMEWHAT AGREE 20%
SOMEWHAT DISAGREE 14%
STRONGLY DISAGREE 44%
DON’T KNOW/REFUSED 4%
Question: How concerned are you that your current health insurance will change if Congress passes health reform legislation? Are you ...?
VERY CONCERNED 47%
SOMEWHAT CONCERNED 24%
NOT VERY CONCERNED 9%
NOT CONCERNED AT ALL 17%
NOT APPLICABLE/ I 3%
CURRENTLY DO NOT HAVE
HEALTH INSURANCE
DON’T KNOW 1%
Question: Let's say Congress proposed a bill that would reduce some health insurance benefits for senior citizens in order to provide health insurance for some people who are uninsured. Would you support or oppose this bill?
STRONGLY SUPPORT 13%
SOMEWHAT SUPPORT 15%
SOMEWHAT OPPOSE 20%
STRONGLY OPPOSE 48%
DON’T KNOW 4%
###
On September 29th, the New York Times reported:
Former Drug Executive Convicted of Wire Fraud
In a verdict that could strike fear into pharmaceutical industry executive suites, the former head of a drug company was convicted of wire fraud Tuesday for issuing what federal prosecutors called a misleading press release that contributed to off-label sales of his company’s drug.
(Full story here: http://www.nytimes.com/2009/09/30/business/30drug.html)
There are rules that need to be followed and there are consequences for those who play fast and loose with them.
Except, it seems, if you are the rule-maker.
Here’s an FDA announcement that appeared Friday (October 16th):
FDA Approves New Indication for Gardasil to Prevent Genital Warts in Men and Boys
The U.S. Food and Drug Administration today approved use of the vaccine Gardasil for the prevention of genital warts (condyloma acuminata) due to human papillomavirus (HPV) types 6 and 11 in boys and men, ages 9 through 26.
(Full FDA release here: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm187003.htm)
Wonderful public health news and certainly worth promoting. And kudos to the FDA for using a regulatory action to discuss an important public health issue.
The interesting issue is how the release ends:
“Gardasil product information: www.fda.gov/cber/products/gardasil.htm”
That link doesn’t bring you directly to the package insert, but rather to a page where you can access the package insert.
Would a pharmaceutical company be permitted to forward such an FDA announcement along to others without more detailed risk information? What about posting the FDA announcement to a commercial website? What about handing it out to physicians?
In 2002, when I was the FDA's associate commissioner for external relations, Dr. Janet Woodcock (then, as now, CDER Director) came in to my office and she was not smiling. She waved a draft of a new drug approval press release at me and asked, "How is anybody supposed to understand this? It's written for scientists!"
I felt her pain. My answer to Dr. Woodcock was that the press office had written a much more consumer-friendly document, but that the release had, quite literally, been doctored when sent to the Center for Drug Evaluation and Research for review. Rather than focusing on the important public health message intrinsic in the new drug approval, the career science staff insisted on putting in more science. "Well," she said, "that's not going to happen anymore." And that was the beginning of a beautiful relationship.
What that story demonstrates—and why I never tire of retelling it—is that communications at the FDA is a perfect example of the maxim, "It's not what we say that matters—it's what our target audience remembers." All the science in the world—precise and important as it may be—is not going to help the average consumer understand why a new drug is important, why it was approved, or even what it does.
So, this isn’t about FDA needing to add more risk information – their release speaks in plain English to the general population. Well done. The question is, shouldn’t pharmaceutical companies be allowed to do the same? Isn’t a clear message in the best interests of the public health? What’s required is a more titrated approach to communications that -- like DTC TV guidance -- provides a clear pathway for achieving compliance while respecting the inherent space/time limitations of any given medium.
John M. Taylor, III will occupy a new position at FDA, Counselor to the Commissioner, where he will oversee the agency's crisis response functions as well as advise on a range of policy and regulatory matters. An attorney, Mr. Taylor served previously with FDA as a staff lawyer, an advisor to previous Commissioners, and as Associate Commissioner for Regulatory Affairs. He most recently has been Executive Vice President, Health, at the Biotechnology Industry Organization, after serving as a Divisional Vice President for Federal Governmental Affairs at Abbott Laboratories.
I served with John and he is a stand-up guy. Great hire.
Now the other news:
Peter G. Lurie, MD, MPH, will serve in the agency's Office of Policy, where he will help develop strategies to facilitate medical product availability to meet critical public health needs, reporting to the Assistant Commissioner for Policy. Dr. Lurie has most recently been Deputy Director of Public Citizen's Health Research Group in Washington, DC and is an adjunct faculty member at Johns Hopkins Bloomberg School of Public Health and the George Washington University School of Public Health and Life Sciences.
I’ve debated Peter. Smart guy. Highly political guy. Public Citizen’s well-known position on “medical product availability” is that most products are “too dangerous.” What’s next? Sid Wolfe as FDA’s Philosopher-in-Residence?
Josh Sharfstein -- similarly.
Ann Witt, health counsel extraordinaire to Representative Henry Waxman(and who previously served as acting director of DDMAC and advisor to the Commissioner), is returning to the FDA to serve in the agency’s Office of Policy, Planning and Budget.
Does this mean Ms. Witt will fill Jeff Shuren’s shoes? (Jeff is currently serving as the Acting Director at CDRH.) That would give Ann the platform to address some of her favorite issues such as off-label communications, advisory committee operations, and the medical device review process. It’s also interesting to note that Ms. Witt was a key player in Dr. Kessler’s (failed) attempt to claim regulatory authority over tobacco.
Following a video welcome from his boss, FDA Commissioner Peggy Hamburg (who advised the audience they weren’t obligated to laugh at any of Josh’s jokes), Dr. Sharfstein spoke about the five issues driving reform over at CDRH. They are:
(1) The development of predictable pathways. Good to hear that the corner office understands that predictability is an important public health issue.
(2) 510(k) reform (and the IOM study of same). Josh noted that “not everyone” was unhappy with the status quo.
(3) Development of a comprehensive compliance strategy. Urgent since the absence of such a program dilutes credibility for both regulator and regulated.
(4) A total lifecycle approach to post-market safety. A la REMS – this (at least in theory) gives the agency greater comfort to approve riskier products.
(5) Better communication of why (and how) CDRH reaches its decisions. This jives with the agency’s broader transparency initiative (which is being coordinated by Sharfstein).
Josh lauded Acting CDRH Director Jeff Shuren, noting that he (Jeff) wasn’t just keeping the seat warm until a permanent director can be appointed, but had the full faith and authority of the Commissioner to drive the above five-pointed program forward.
Jeff Shuren is a serious guy and whip-smart. An MD and a JD – he now completes the triad as (acting) indian chief.
The commission wants to know whether the scope of such community-wide authorization procedures should be optional, with the choice being left to the sponsor. Also, it asks whether such procedures should cover all clinical trials preformed in the EU or whether they should be limited to only some clinical trials (for example multinational trials).
Stakeholders are asked to submit feedback on which option is preferable and on the practical and legal issues that would have to be considered if they were to be adopted.
While ethical issues clearly fall within the remit of member states and would remain there, the commission has several suggestions to ensure better co-operation and exchange among national ethics committees to improve the ethical review of clinical trials.
The consultation document contains several examples of inconsistencies in the current application of the directive in member states.
For example, there are different interpretations of what could be considered a substantial amendment; this has resulted in a situation whereby the company regards something as a substantial change more often than it actually should in order to avoid problems of non-compliance.
Also, problems relating to the reporting of suspected unexpected serious adverse reactions (SUSARs) have led to multiple reporting of the same SUSAR, lack of reporting and unreliability of community data on SUSARs. Moreover, the number of SUSARs received differs disproportionately among some member states.
The consultation document builds on the findings and recommendations of an EU-funded study – the Impact on Clinical Research of European Legislation (ICREL) – that was issued earlier this year. The ICREL project was initiated in January 2008 and it measured the impact of the directive on four key stakeholder groups – commercial and non-commercial clinical trials sponsors, competent authorities and ethics committees – between 2004 and 2007.
All fine and good and important and timely – but what about enhanced harmonization with, among others, the United States? First things first perhaps, but the transatlantic issue must be addressed – and sooner rather than later.
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