Latest Drugwonks' Blog
Food & Beverage Industry Announces Front-of-Pack Nutrition Labeling Initiative to Inform Consumers and Combat Obesity
(Washington, D.C.) America’s leading food and beverage manufacturers and retailers joined forces today in the fight against obesity and announced their commitment to develop a new front-of-package nutrition labeling system. The unprecedented consumer initiative will make it easier for busy consumers to make informed choices when they shop.
This program will add important nutrition information on calories and other nutrients to limit to the front of the packages of many of the country’s most popular food and beverage products. To appeal to busy consumers, the information will be presented in a fact-based, simple and easy-to-use format. In the coming months, the Grocery Manufacturers Association (GMA) and the Food Marketing Institute (FMI) will finalize the details of the initiative, including the technical and design elements. In addition, details will be finalized on how to provide consumers with information on nutrients needed to build a “nutrient-dense” diet and on “shortfall nutrients” that are under-consumed in the diets of most Americans. GMA and FMI will continue to consult stakeholders on these and other details in the coming weeks.
Consumers will begin to see the new label in the marketplace early next year.
To build consumer awareness and promote use of the new label, America’s food and beverage manufacturers and retailers have agreed to support the change to their product labels with a $50 million consumer education campaign. The campaign, to be launched in 2011, will be aimed at parents who are primary household shoppers.
Acne Cream? Tax-Sheltered. Breast Pump? No.
By DAVID KOCIENIEWSKI
Published: October 26, 2010
Denture wearers will get a tax break on the cost of adhesives to keep their false teeth in place. So will acne sufferers who buy pimple creams
A breast pump and various accessories can run about $500 to $1,000 for most mothers a year.
People whose children have severe allergies might even be allowed the break for replacing grass with artificial turf since it could be considered a medical expense.
But nursing mothers will not be allowed to use their tax-sheltered health care accounts to pay for breast pumps and other supplies.
That is because the Internal Revenue Service has ruled that breast-feeding does not have enough health benefits to quality as a form of medical care.
You can't make this stuff up...
www.nytimes.com/2010/10/27/business/27breast.html
“Anyone who isn’t confused really doesn’t understand the situation.”
-- Edward R. Murrow
On November 2nd, from 12:15-1pm the FDA is holding a teleconference to discuss the agency’s risk communications research agenda.
45 minutes?
The teleconference will begin with a presentation by the FDA on its research agenda and its role in supporting the agency’s strategic plan for risk communications by “strengthening the science of risk communications.”
This will be followed by a panel of FDA’s social scientists and a Q&A.
FDA and social science? Maybe 45 minutes begins to make more sense.
Be there or be square.
“The speed of communications is wondrous to behold. It is also true that speed can multiply the distribution of information that we know to be untrue.”
-- Edward R. Murrow
Talk about biting the hand that feeds you. Puerto Rico, long home to pharmaceutical manufacturing facilities, has just passed a new law (Law 154) that imposes “special taxes” on non-resident companies. That means all of the “Big Pharma” firms doing business on the island.
According to a 2006 survey, the biopharma sector supports over 94,000 jobs in Puerto Rico and conducted 425 clinical trials on the island commonwealth.
It should also be noted that Law 154 was enacted minus any public input or comment.
Adios.
From Business Week:
"A key U.S. Senator is asking federal officials to investigate after reviewing data that shows doctors across the country prescribing alarmingly high numbers of powerful mental health drugs paid for by Medicare and Medicaid..
Grassley did not name the doctor, but state records obtained by The AP show Dr. Fernando Mendez-Villamil wrote an average of 153 prescriptions a day for 18 months ending in March 2009. That's nearly twice the number of the second highest prescriber in Florida, who wrote a little more than 53,000 prescriptions, according to a list compiled by state officials.
The doctor's attorney, Robert Pelier, said his client tried to contact Grassley to explain the data but got no response.
"Dr. Mendez-Villamil is a specialist that has treated the most afflicted and poor in the area" and has never acted improperly, Pelier said. He filed a lawsuit against the state alleging authorities tried to terminate him from being a Medicaid provider "without cause."
Federal officials said they stopped reimbursing Villamil after Grassley inquired about the doctor to HHS in December."
Nice work. And welcome to another aspect of Obamacare: Targeting and terminating payment of doctors who are fingered by the feds for providing "too much" treatment.. Having Grassley serve as a bounty hunter is optional.
I thought it would be nice to hear Dr. Mendez-Villami's side of the story since most media accounts gloss over it. I found this letter he wrote to HHS. You tell me if this sounds like a crook or just one more honest and hardworking doctor who will ultimately bag Medicaid because of the reimbursement cuts and threat of retaliation.
PS.. Here's something CMS and Grassley overlooked: No one gets rich writing prescriptions.. Where is the fraud. Is it a criminal activity to prescribe more than what a Senator regards as "normal?"
Why isn't anyone raising hell about this abuse of power?
Dear Senator Grassley,
I am writing to add a human face -- along with some background information and context -- to whatever image you may have of the doctor in Miami who wrote all those prescriptions for mental health drugs.
I am that doctor. My name is Fernando Mendez-Villamil and I have practiced psychiatry in South Florida since 1998. I received my medical degree from the Universidad Central del Caribe in Puerto Rico and performed my residency in psychiatry in Jackson Memorial Hospital, the public medical center serving metropolitan Miami.
I can only imagine what you thought when you were given information by the Florida Agency for Health Care Administration showing that one doctor wrote close to 97,000 prescriptions for mental health drugs over 21 months. This came to 153 prescriptions a day, 7 days a week for that entire period; twice as many prescriptions in that period as the number 2 Medicaid prescriber in the state.
These numbers may have struck you as an indication something was wrong. Frankly, since I have never stopped to do such a calculation, it seemed a little peculiar to me too. I never felt I was treating an extraordinary number of people or writing an exceptional number of prescriptions.
At the same time, I never thought I would be faulted for working hard or for being very organized and efficient. But now - with this publicity and the questions it has engendered - I have looked at the matter carefully and would like to provide you and the public with some context within which to consider these facts.
First, I want you to know that I take very good care of my patients. My top priority is to improve their conditions. In more then ten years of practice I have worked with thousands of afflicted individuals. Their conditions have ranged between mild emotional upset to extreme debilitating psychosis.
By every indication, my patients and their families are pleased with my care.
I may be an oddity as a physician because I do not play golf, I do not have a boat and I seldom leave my practice for extended vacations and am involved in my practice on a daily basis. That is not to solicit sympathy or to appear “noble.” I am simply committed to my patients, profession and enjoy what I do and do not seek distractions.
As to my patients, they share some characteristics.
* Many receive a combination of medications with each drug addressing specific aspects of their condition identified by the use of objective clinical findings along with subjective complaints. Therefore, when I see such patients I must write or renew an average of three or four prescriptions.
* Some patients come to me after having been under the care of other medical providers who prescribed some of these medications. I must evaluate whether those drugs are effective in achieving their treatment objectives, whether some medications should be discontinued and whether additional medications are required. This can be a very difficult process when I am dealing with a mentally ill patient who may not be able to assist fully in the examination process. I would like you to know that these efforts are in combination with initial and ongoing psychiatric assessments of my patients.
* Ongoing treatment plans with the use of atypical antipsychotic medication is necessary in order to maintain patients stable and effectively responsive to their mental health needs. I firmly believe that a person’s health should not be placed in danger by erratic or ineffective treatment.
* As a result of my assessments and treatment plans I have initiated; most of my patients are very stable and experience very few changes in behavior or in their medical condition over time. Of great importance is the fact that hospitalization rates of my patient population are less than 1%. Hospitalization can be costly and otherwise interrupt the mental health and wellbeing of the patients. While I seek to be alert of subtle variations in my patient’s responsiveness to the treatment or behavior that might indicate a need to alter their regimen, you may appreciate that my patients are not always able to reliably explain how a drug is affecting them. Chronic mental health patients require complex combinations of medications based on their past treatment, physiological and psychological needs.
As to the specific prescriptions I have written, I have asked the Florida Agency for Healthcare Administration to provide me the information that was presumably provided to you and consequently to media outlets. The department has responded to my request by saying they have not received any recent requests for information about me or my practice and could therefore not furnish me with such information.
The information received from this agency advised that I am not under any sort of investigation. It also appears that the circumstances surrounding the release of the information to you supports this also. This was good to hear because I would hate to think that the government would discourage hard work and efficiency in the delivery of medical care.
In a similar vein, I was very surprised to read in the Miami Herald that Medicare had supposedly stopped payment for my services; and I am very pleased to confirm with Medicare officials that this was NOT true.
As to the numbers of prescriptions that have been cited, let us look at them on a hypothetical basis and see what they show.
Assuming the numbers are correct, I wrote 97,000 prescriptions in 21 months.
AHCA does not indicate how many patients were involved. However, again assuming those numbers are correct I believe the following would outline the pertinent facts in this matter.
Spread over 21 months, on an average six day, sixty to sixty-three hour work week that comes to approximately 4619 prescriptions per month. It is also not uncommon for me to actually work beyond these hours if there patients that need to be seen; as my practice is mainly a walk in, first come first served office.
At my average work schedule of 22-24 days per month, that means I saw between 47-55 patients a day and wrote an average of 210 prescriptions. That averages to 2-3 prescriptions per patient per appointment. Please remember that most of my patients are seen every other month; are given refills and my services are focused on the ongoing administration, effectiveness and responsiveness of the medication treatment plan I have prescribed for these patients. Time wise, I average 10-15 minutes per patient.
Generally, I work an average workday of 11-12 hours. Not counting one hour in the aggregate for lunch and other non patient related activities, I see roughly four patients per hour.
Given the stable nature of my patients –these efforts are reasonable and well within the norms of modern psychiatric practice and in treating my patient population. This is especially true given that mine is a psychiatric practice that rarely involves time-consuming psychotherapy, physical contact or examination of the full range of vital signs. Please keep in mind that the interaction I have with my patients is a combination of patient assessment, monitoring and evaluation of a continuing course of treatment as to the effectiveness of the patient’s medication regimen and/or treatment.
Senator, I certainly appreciate your efforts to monitor matters such as this. Our country’s health care system is vast and complicated and seemingly includes much inefficiency. I hope you continue your good work with vigilance and determination.
However, in my case I assure you there is absolutely no cause for concern or alarm.
And I probably COULD use a nice vacation.
Respectfully,
Fernando Mendez-Villamil, M.D.
EMAIL: mendezvillamildr@gmail.com
cc: The Honorable Kathleen Sebelius
Secretary, U.S. Department of Health and Human Services
Charlene Frizzera
Acting Administrator, Centers for Medicare and Medicaid Services
U.S. Department of Health and Human Services
The Honorable Thomas W. Arnold
Secretary, Agency for Health Care Administration
State of Florida
And speaking of PDUFA reauthorization – wait, time out.
FDA has proposed a new application review model that would allow it to call a time-out, which could be used to resolve mid-cycle issues.
The idea seems to be an admission by the agency that the six and ten month review times for priority and standard applications, respectively, are no longer sufficient to actually complete a review.
So, it’s not really an issue of “time out” as it is “time on” – as in “time added” at the agency’s discretion.
Minutes of the Sept. 27 industry and FDA Prescription Drug User Fee Act reauthorization negotiation revealed the agency proposed the time-out solution in an effort to create more application review time that will, among other things, allow more feedback to sponsors.
The proposal also could be used to address industry requests for a formal mid-cycle meeting to gain agency feedback on an application’s direction.
But will more feedback result in greater predictability? The length of the review clock stoppage would be fixed, but was not specified in the minutes of the 9/27 meeting.
Industry representatives called for a mid-cycle review in a previous PDUFA negotiating session, but FDA said comprehensive feedback likely was not possible at the midpoint of an application review because its process is not complete. Hm.
An agency willingness to add more meetings to the process is a change from previous discussions with industry, where the agency argued allowing for more meetings could lead to more sponsor questions and create more work for reviewers.
But FDA maintains its previous position that it cannot provide additional application support with the resources it has -- and so its offer for more sponsor-requested meetings means the review time must be extended. Hm.
REMS, FDA, FDAAA, FTC, ANDA ...
The Federal Trade Commission is looking into whether companies are using REMS to thwart generic competition.
Markus Meier, assistant director of the Health Care Division in FTC’s Bureau of Competition, said he had seen two ways a company may use REMS to block generics: preventing generic companies from getting samples of the drug for bioequivalence testing, or making it difficult for a generic to participate in its REMS program.
“Some systems are so restricted that there is nowhere to buy the product except to buy it from the branded company,” he said. If the branded company refuses to sell it then the generic cannot do bioequivalence testing and therefore cannot file an ANDA and “potentially there will never be generic competition for the product.”
Hm. “Spirit” of FDAAA notwithstanding, can a company be “forced” to sell its product to a competitor? Interesting IP question.
Meier said FTC has also seen some instances in which the generic company got sufficient samples and filed an ANDA and then had to come within the branded company’s REMS to start marketing their product. At that point “the branded company tries to impose onerous requirements for participation in the program so that it makes it difficult for the generic to actually qualify,” he stated.
Hm. But don’t all REMS have to be approved by the FDA? Minus more directive practices from the agency, well, if you’re not part of the solution …
“I’m not saying that’s been proven,” Meier added. “I’m not saying we’ve made that accusation of anybody but we’re looking at it. And one of the reasons we’re looking at is because the statute (FDAAA) expressly prohibits participants in these programs from using REMS to erect barriers to competition.”
As for dealing with potential REMS abuse, Meier said FDA does not believe it has any mechanism to enforce the FDAAA provision prohibiting a company from using a REMS to block or delay approval of an ANDA. But “onerously prescriptive” is certainly in the eyes of the beholder. Is a REMS that’s tough for the proper public health reasons somehow wrong if it restricts entry of a generic and/or follow-on product?
Certainly not.Will FDA tighten standards for generic drugs? According to CDER Director, Dr. Janet Woodcock – the answer is “yes.” Good call.
At a meeting of the Generic Pharmaceutical Association in Bethesda, Maryland, Janet said the agency is discussing tightening the limits "so there is less variability.”
Less variability equals better predictability.
Dr. Woodcock commented that patients have complained about generic anti- seizure medications not working as well as brand-name counterparts.
This strikes a very personal note for me. One of my sons has Juvenile Myoclonic Epilepsy. His condition is wonderfully controlled via his meds – and I’d like it to stay that way.
Woodcock said that industry executives have approached her with concerns that some generic drugs have spurred quality concerns that went unnoticed in the approval process because clinical testing includes too few patients.
“They say, ‘I know there are products out there that aren’t equivalent,’ and typically they’re manufacturing folks,” Woodcock said in her speech. “I’ve heard it enough times from enough people to believe that there are a few products that aren’t meeting quality standards.”
Woodcock said she didn’t know when the agency would come to any conclusions about generic standards of equivalence. The standards assure the generic is absorbed at the same rate and extent as the brand-name version.
The absorption problems aren’t necessarily harmful, Woodcock said. FDA permits generic drugs to absorb at a 25 percent different rate and extent than the originals they copy.
In April, a group of outside FDA advisers, the Pharmaceutical Science and Clinical Pharmacology Advisory Committee, voted 11-2 that the agency’s equivalence requirements aren’ sufficient for certain medicines. They didn’t offer an alternative, and suggested the FDA list “critical dose drugs,” or drugs where a small difference in concentration can change patients’ reaction, that may need new standards.
The Pharmaceutical Science and Clinical Pharmacology Advisory Committee voted unanimously, with one abstention, that critical dose drugs do constitute a distinct group and voted unanimously that FDA should develop a formal list of those drugs - although the terminology of "narrow therapeutic index" may be more appropriate. And in an 11-2 vote, the committee concluded that current bioequivalence standards are not sufficient for drugs in the narrow therapeutic index group.
Critical dose drugs have a narrow therapeutic index, meaning that "small changes in blood concentration have the potential to result in serious therapeutic failures and/or serious adverse drug reactions." FDA is consulting the committee on the need to establish separate bioequivalence criteria for these drugs given continuing debate about whether critical-dose drugs require special consideration, the agency explained.
Currently, the "sameness" of a brand product and a generic version is evaluated based on two-treatment crossover study to prove bioequivalence, the aim being to show that the 90 percent confidence intervals of the geometric mean test/reference ratios for both maximum plasma concentration and the area under the plasma concentration-time curve fall within a range of 80 percent to 125 percent.
It’s good news that the FDA is taking a strong stance in favor of the public health – because there will be many who seek to undermine this important initiative.
For those of you waiting for FDA to reveal the magical regulations that will unleash the power of healthcare social media – don’t hold your breath.
According to DDMAC Director Thomas Abrams, some social media guidance might be released by the end the year and will address issues related to Internet drug promotion --not how to use specific social media tools like Facebook, YouTube and Twitter
“What we’re going to do is address questions like how to respond to unsolicited requests for information, what’s the corporate responsibility for correcting and monitoring third party sites for misinformation, what’s the corporate accountability for having people post promotional videos and things like that,” Abrams said during a Food and Drug Law Institute conference on enforcement.
And things like that.
In other words, and as predicted, the low hanging fruit.
Since last November’s Part 15 hearing, DDMAC has communicated that efficacy claims must be accompanied by risk information and cast doubt on the concept of a “One-Click Rule.” So much for regulations setting pharma free.
“In an instant all will vanish and we'll be alone once more, in the midst of nothingness!"
-- Waiting for Godot
For more on why industry shouldn’t wait for regulatory holy writ, see here.
Peter has written a lot on comparative effectiveness research and has some suggestions about how to encourage it and conduct it in ways that promote better care and less cost. As the Economix blog put it: "using the research not to decide whether to cover a procedure but instead to decide how much to pay for it. If there isn’t research showing that a more expensive treatment is more effective than a cheaper treatment, then the reimbursement rate for the cheaper treatment applies to both." Of course if a more expensive treatment is more effective than it should be paid for.
I don't trust the motives of many who make up the CER community and believe that CER research contributes nothing to the goal of improving clinical decisionmaking. Uwe Reinhardt's fippant assertion that differences in clinical pratice can't be controlled for is completely wrong and self serving since Reinhardt endorses using average outcomes of average populations with minimal risk adjustment to decide who gets what. For Reinhardt's smug analysis: economix.blogs.nytimes.com/2010/10/15/basing-pay-for-performance-on-outcomes/
I believe Peter is the exception. The links to his articles and those written about his work are below. He offers a sensible starting point for developing an alternative to the CER slush fund.
jama.ama-assn.org/cgi/content/short/304/15/1719
www.theledger.com/article/20101020/ZNYT01/10203007
economix.blogs.nytimes.com/tag/us-health-care-costs/
content.healthaffairs.org/cgi/content/abstract/29/10/1796
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.
