In large type, The New York Times made a page 1 announcement of a "Deal in Place For Inspecting Foreign Drugs." The article details that generics producers would pay yearly fees of $299 million to finance inspection of non-U.S. based manufacturing plants every 2 years.
This announcement gives me no comfort. The major pharmaceutical company payers control too much of the offshore inspection budget of the FDA and that power of control raises too high a risk of corruption of the system. If Congress approved a fee structure with dollars flowing into the U.S. general fund, rather than being earmarked specifically for FDA offshore inspections, and reasonable appropriations were made by Congress to support the FDA offshore inspection program, there would be a healthy separation between the payers and the FDA/Inspectors. As the proposal now stands, it sounds as if the pharmaceutical industry has strengthened its stranglehold on the FDA, offshore inspections, control of generics, and perhaps on Congressional campaign budgets and solicitations. Keep your eye on that hen house and remember that the foxes are only interested in taking care of themselves.
Showing posts with label Generic. Show all posts
Showing posts with label Generic. Show all posts
Saturday, August 13, 2011
Monday, August 8, 2011
A Good Question
A reader asks: "What of Congressional/presidential action that would prevent minor [or major] generic drug price increases." I have waited a few days before responding because I think this serious question deserves thought, rather than a glib answer.
Some of my readers may have read Ezekiel J. Emanuel's "Opinion"article in the Sunday Review section of August 7, 2011's New York Times which touches on some of the issues related to a shortage of generic drugs effective against some cancers. If you haven't read it, you should for it illustrates some of the complexities in this troubling area. [Some of my readers may recall my discussion of the Thursday lunch discussions at which oncologists described their difficulties in obtaining chemotherapy drugs to give their patients, which they ascribed to their purchasing drugs which patients were unable to pay them for, inability to get authorization from some insurers to pay for the drugs (or insurer authorization presenting expensive time-consuming bureaucratic hurdles to authorization), or difficulties accessing the drugs or being paid for their time, energy and staff whose burned up financial resources in the process.] Several of my oncologist colleagues, who were superb physicians, have retired from their practices because (as they expressed it) of dissatisfaction with their ability to properly treat patients under the existing health care practice conditions and because they were operating their practices at a financial loss.)
I have discussed some of the issues concerning the scarcity of generics, and their rising prices (inadequately offset for Medicare Part D patients by price increases for generics which offset any savings the government may have garnered for them when they reach the doughnut hole (i.e., 7%). Congress and the President have the capacity to use governmental tools to answer significant questions and take action based on their findings: 1) has there been significant consolidation among generic drug producers (including those offshore) which reduces competition in the industry to the detriment of patients? 2) have large pharmaceutical companies acquired generic drug producers, or entered into joint operating agreements with them, which effectively reduces competition to the detriment of patients? 3) is the federal trade commission carrying out its intended function of promoting competition, or has it been sidelined to protect drug manufacturers from competition? 4) is the legal strategy of certain large pharmaceutical companies inhibiting the appearance of generic versions of their "branded" drugs when they go "off-patent"? 5) is the generic drug approval process inhibiting adequate public access to generics in reasonable quantities and at appropriate prices? 6) does the public have adequate information about the sources (country of origin, capability of the manufacturer, and quality of drug) of generics currently being sold in the United States and is that information based on appropriate investigation of those companies by an FDA which is adequately funded by Congress to carry out those functions? 7) Is the Orphan Drug Law being subverted through the introduction of a drug as a treatment for a rare serious disease and then the application of that drug to other treatments at a protected artificially high price? 8) is there financial transparency throughout the entire drug pharmaceutical production and distribution process or are there numerous unknown intermediaries who jack up the price of drugs without tendering services of commensurate value? 8) is our patent law artificially creating shortages of life saving generic drugs? 9) is the rebate, discount and kickback system applied by pharmaceutical insurers, the government and other actors in this field destructive of consumer protection? 10) and finally, does anyone with political power and authority really give a damn?
Some of my readers may have read Ezekiel J. Emanuel's "Opinion"article in the Sunday Review section of August 7, 2011's New York Times which touches on some of the issues related to a shortage of generic drugs effective against some cancers. If you haven't read it, you should for it illustrates some of the complexities in this troubling area. [Some of my readers may recall my discussion of the Thursday lunch discussions at which oncologists described their difficulties in obtaining chemotherapy drugs to give their patients, which they ascribed to their purchasing drugs which patients were unable to pay them for, inability to get authorization from some insurers to pay for the drugs (or insurer authorization presenting expensive time-consuming bureaucratic hurdles to authorization), or difficulties accessing the drugs or being paid for their time, energy and staff whose burned up financial resources in the process.] Several of my oncologist colleagues, who were superb physicians, have retired from their practices because (as they expressed it) of dissatisfaction with their ability to properly treat patients under the existing health care practice conditions and because they were operating their practices at a financial loss.)
I have discussed some of the issues concerning the scarcity of generics, and their rising prices (inadequately offset for Medicare Part D patients by price increases for generics which offset any savings the government may have garnered for them when they reach the doughnut hole (i.e., 7%). Congress and the President have the capacity to use governmental tools to answer significant questions and take action based on their findings: 1) has there been significant consolidation among generic drug producers (including those offshore) which reduces competition in the industry to the detriment of patients? 2) have large pharmaceutical companies acquired generic drug producers, or entered into joint operating agreements with them, which effectively reduces competition to the detriment of patients? 3) is the federal trade commission carrying out its intended function of promoting competition, or has it been sidelined to protect drug manufacturers from competition? 4) is the legal strategy of certain large pharmaceutical companies inhibiting the appearance of generic versions of their "branded" drugs when they go "off-patent"? 5) is the generic drug approval process inhibiting adequate public access to generics in reasonable quantities and at appropriate prices? 6) does the public have adequate information about the sources (country of origin, capability of the manufacturer, and quality of drug) of generics currently being sold in the United States and is that information based on appropriate investigation of those companies by an FDA which is adequately funded by Congress to carry out those functions? 7) Is the Orphan Drug Law being subverted through the introduction of a drug as a treatment for a rare serious disease and then the application of that drug to other treatments at a protected artificially high price? 8) is there financial transparency throughout the entire drug pharmaceutical production and distribution process or are there numerous unknown intermediaries who jack up the price of drugs without tendering services of commensurate value? 8) is our patent law artificially creating shortages of life saving generic drugs? 9) is the rebate, discount and kickback system applied by pharmaceutical insurers, the government and other actors in this field destructive of consumer protection? 10) and finally, does anyone with political power and authority really give a damn?
Monday, July 25, 2011
Medicare and Retirees - Watch Out for Rising Generic Prices
I have noticed an increase of $1.00 to about $10.00 in the cost of generics I use. Perhaps you have had similar experiences, wonder why and ask yourselves how this will affect your financial security.
The pharmaceutical business is just another free enterprise business which places profits at the top of its accomplishment list when it reports to shareholders and seeks financial support from bankers and investment sources. Brand name drug manufacturers may have subsidiaries which produce generics, and as their patent franchises (i.e., Lipitor and Plavix) expire, you can expect those subsidiaries (or competing generic companies) to be producing generic versions of the branded drugs and to reflect their free-enterprise priorities in doing so. The insurance business, another free-enterprise (subject to some regulation) operation, generates profits by contracting to pay less for the drugs sold to you then your premiums reflect. The difference between their revenues (premiums, copays, rebates, etc.) and their costs (less rebates, etc.) for the drugs they cover pays the big bucks to their executives and more modest returns to individual shareholders.
When the price of a generic increases by a dollar, you, the purchaser, must have $100 in your bank account (at current interest rates) to generate the interest to cover your extra dollar in cost. If you fill 30 generic prescriptions a year you must have thousands of dollars in your bank account to have your interest cover your extra costs. The "minor" increase in generic prices will soon eat away your savings and assets because with the current rate of generic price acceleration that I have seen, you will have to be well-off to generate the return on investment sufficient to pay for the inflation in your drug charges. Obama's health reform plan may control the long-term doughnut whole growth that we have seen in the last two years but seniors and retirees need to pay attention to a political environment where formidable anti-health care reform pressures are being exerted by the party in opposition.
The "minor" increase in generic costs will have a major effect on Medicare-covered Americans and retirees. Make your insurance plan, including Medicare Part D, choice carefully. Shop carefully. And let your Congress people know that you understand what is going on and you expect them to respond to constituent's needs, and not let "minor" generic price increases bankrupt this voting population.
The pharmaceutical business is just another free enterprise business which places profits at the top of its accomplishment list when it reports to shareholders and seeks financial support from bankers and investment sources. Brand name drug manufacturers may have subsidiaries which produce generics, and as their patent franchises (i.e., Lipitor and Plavix) expire, you can expect those subsidiaries (or competing generic companies) to be producing generic versions of the branded drugs and to reflect their free-enterprise priorities in doing so. The insurance business, another free-enterprise (subject to some regulation) operation, generates profits by contracting to pay less for the drugs sold to you then your premiums reflect. The difference between their revenues (premiums, copays, rebates, etc.) and their costs (less rebates, etc.) for the drugs they cover pays the big bucks to their executives and more modest returns to individual shareholders.
When the price of a generic increases by a dollar, you, the purchaser, must have $100 in your bank account (at current interest rates) to generate the interest to cover your extra dollar in cost. If you fill 30 generic prescriptions a year you must have thousands of dollars in your bank account to have your interest cover your extra costs. The "minor" increase in generic prices will soon eat away your savings and assets because with the current rate of generic price acceleration that I have seen, you will have to be well-off to generate the return on investment sufficient to pay for the inflation in your drug charges. Obama's health reform plan may control the long-term doughnut whole growth that we have seen in the last two years but seniors and retirees need to pay attention to a political environment where formidable anti-health care reform pressures are being exerted by the party in opposition.
The "minor" increase in generic costs will have a major effect on Medicare-covered Americans and retirees. Make your insurance plan, including Medicare Part D, choice carefully. Shop carefully. And let your Congress people know that you understand what is going on and you expect them to respond to constituent's needs, and not let "minor" generic price increases bankrupt this voting population.
Tuesday, May 3, 2011
Voluntary Coumadin Recall
http://www.fda.gov/Safety/Recalls/ucm253523.htm :
Bristol-Myers Squibb Initiates a Nationwide Voluntary Recall of Coumadin® (Warfarin Sodium) Crystalline 5 mg Tablets, Lot Number 9H49374A
When I clinically practiced as an hematologist, I dealt with a variety of anticoagulants, both as an initiator of treatment and as a consultant called when things went wrong. I have seen anticoagulants, such as warfarin (trade name - "Coumadin") and heparin (and its derivatives) save lives, and I have seen them cause severe bleeding (and other) complications including death. In practice, I constantly kept in mind the 2% case-fatality rate associated with warfarin and the particular risk that was seen in frail elderly women for whom it was prescribed.
The indications for warfarin treatment usually involved the formation of blood clots in the venous system and the risk that a clot would dislodge, travel to the lungs as a pulmonary embolism, and cause death or severe lung damage. At Stanford, I trained with hematologist Professor Edward Hershgold, who taught us great respect for warfarin, expounding on accumulated clinical research with this drug, and drilling us on its ability to induce anticoagulation slowly (over 7-10 days), sometimes when laboratory tests suggested that it had more quickly achieved its intended effect.
In my consultant practice, I saw the dark side of warfarin when physicians who used warfarin infrequently did not carefully and fully educate their patients on the proper use of warfarin, dietary management, the risks of drug interactions with medications commonly prescribed by physicians, and the requirement for frequent laboratory testing of the"prothrombin time" and "INR" in following the appropriateness of the anticoagulation level achieved. In our health law practice, we saw physicians charged with being inconsistent in testing their patients for anticoagulation and then properly communicating with their patients about the results of their tests and prescribing instructions, sometimes with serious adverse consequences which endangered their medical licenses.
With all of those considerations in mind, I highlight a voluntary Coumadin recall of one lot of Coumadin by its manufacturer Bristol-Myers Squibb as as a precautionary measure based on the company’s testing of tablets from a returned bottle. A single tablet was found to be higher in potency than expected.
If any of my readers take Coumadin or have friends or family taking Coumadin, I suggest that they refer to the link to the FDA release and follow the recommendations in that FDA release. For those who require anticoagulation, the dose (generic or brand name) must be just right, not too high or too low.
FOR IMMEDIATE RELEASE - May 2, 2011 - Bristol-Myers Squibb initiated a voluntary recall of one lot of 1,000-count bottles of Coumadin® (warfarin sodium) Crystalline 5 mg tablets. Bottles of 1,000 tablets are distributed to pharmacies for further dispensing to patients in prescription quantities. The lot number affected in the U.S. is 9H49374A with an expiry date of September 30, 2012. The recall is a precautionary measure based on the company’s testing of tablets from a returned bottle. A single tablet was found to be higher in potency than expected.
Coumadin is prescribed to treat or prevent blood clots. A decrease of active ingredient may increase the risk of clots which could lead to heart attack or stroke and if there is too much active ingredient, there is an increased risk of bleeding.
Patients who may have 5 mg tablets should not interrupt their therapy but should seek advice from their pharmacist to see if they have tablets originating from the affected lot and if so, should consult their physician for appropriate medical advice.
Bristol-Myers Squibb is committed to ensuring patient safety and is working to resolve this issue quickly and appropriately. The company has notified the U.S. Food and Drug Administration (FDA), and will issue recall communications to all physicians and other customers involved.
Any adverse reactions may be reported to the FDA's MedWatch Program by fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov.
Health care professionals and customers may call the following for assistance if they have further questions about the recall:
For information related to this recall:
Stericycle, Inc.
1-866-918-8739
Bristol-Myers Squibb Initiates a Nationwide Voluntary Recall of Coumadin® (Warfarin Sodium) Crystalline 5 mg Tablets, Lot Number 9H49374A
When I clinically practiced as an hematologist, I dealt with a variety of anticoagulants, both as an initiator of treatment and as a consultant called when things went wrong. I have seen anticoagulants, such as warfarin (trade name - "Coumadin") and heparin (and its derivatives) save lives, and I have seen them cause severe bleeding (and other) complications including death. In practice, I constantly kept in mind the 2% case-fatality rate associated with warfarin and the particular risk that was seen in frail elderly women for whom it was prescribed.
The indications for warfarin treatment usually involved the formation of blood clots in the venous system and the risk that a clot would dislodge, travel to the lungs as a pulmonary embolism, and cause death or severe lung damage. At Stanford, I trained with hematologist Professor Edward Hershgold, who taught us great respect for warfarin, expounding on accumulated clinical research with this drug, and drilling us on its ability to induce anticoagulation slowly (over 7-10 days), sometimes when laboratory tests suggested that it had more quickly achieved its intended effect.
In my consultant practice, I saw the dark side of warfarin when physicians who used warfarin infrequently did not carefully and fully educate their patients on the proper use of warfarin, dietary management, the risks of drug interactions with medications commonly prescribed by physicians, and the requirement for frequent laboratory testing of the"prothrombin time" and "INR" in following the appropriateness of the anticoagulation level achieved. In our health law practice, we saw physicians charged with being inconsistent in testing their patients for anticoagulation and then properly communicating with their patients about the results of their tests and prescribing instructions, sometimes with serious adverse consequences which endangered their medical licenses.
With all of those considerations in mind, I highlight a voluntary Coumadin recall of one lot of Coumadin by its manufacturer Bristol-Myers Squibb as as a precautionary measure based on the company’s testing of tablets from a returned bottle. A single tablet was found to be higher in potency than expected.
If any of my readers take Coumadin or have friends or family taking Coumadin, I suggest that they refer to the link to the FDA release and follow the recommendations in that FDA release. For those who require anticoagulation, the dose (generic or brand name) must be just right, not too high or too low.
FOR IMMEDIATE RELEASE - May 2, 2011 - Bristol-Myers Squibb initiated a voluntary recall of one lot of 1,000-count bottles of Coumadin® (warfarin sodium) Crystalline 5 mg tablets. Bottles of 1,000 tablets are distributed to pharmacies for further dispensing to patients in prescription quantities. The lot number affected in the U.S. is 9H49374A with an expiry date of September 30, 2012. The recall is a precautionary measure based on the company’s testing of tablets from a returned bottle. A single tablet was found to be higher in potency than expected.
Coumadin is prescribed to treat or prevent blood clots. A decrease of active ingredient may increase the risk of clots which could lead to heart attack or stroke and if there is too much active ingredient, there is an increased risk of bleeding.
Patients who may have 5 mg tablets should not interrupt their therapy but should seek advice from their pharmacist to see if they have tablets originating from the affected lot and if so, should consult their physician for appropriate medical advice.
Bristol-Myers Squibb is committed to ensuring patient safety and is working to resolve this issue quickly and appropriately. The company has notified the U.S. Food and Drug Administration (FDA), and will issue recall communications to all physicians and other customers involved.
Any adverse reactions may be reported to the FDA's MedWatch Program by fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov.
Health care professionals and customers may call the following for assistance if they have further questions about the recall:
For information related to this recall:
Stericycle, Inc.
1-866-918-8739
Saturday, May 17, 2008
Are You Taking The Drugs You Think You Are?
Reasonably sophisticated patients don't order drugs from unknown vendors on the internet. Cautionary tales of counterfeit or adulterated drugs abound, and if one has a serious medical condition, that cheap internet drug may cause trouble, perhaps even death.
But what about the drugs you get from your local or mail order pharmacy? Aren't those drugs certain to be the genuine branded product or a generic bioequivalent?
If you attended law school, the police academy, are a regular viewer of one of the CSI series programs, or if you work for the United States Postal Service handling "Registered Mail" you have probably heard about the "chain of evidence" or "chain of custody." You know that for the chain to be valid, there must be specific contemporaneous written documentation of custody and transfer of custody at each and every step during which it is handled. You might make the assumption that there is a similar chain of evidence for the drugs delivered to you by your pharmacy (local or mail order) in accordance with your doctors' prescriptions. Sorry, this isn't CSI, law school, the Post Office, or a courtroom. If you want to see a puzzled, annoyed, look on your pharmacist's face, ask if he or she knows (and how he or she knows) where and by whom the drug sold to you was produced, whether there is documentation of each step and party in the distribution process, that the drugs you received were actually delivered and received by intermediate parties in the very same sealed containers as they were delivered in, and whether the pharmacist can guarantee that the drug that the pharmacy delivers to you is the genuine branded product or a bioequivalent generic. Unfortunately, our prescription drugs have been commoditized, and the handlers anonymized, so that our faith in the products we receive may be unfounded.
If enough people asked the questions I described, perhaps the distribution process would become transparent instead of opaque. Perhaps instances of expensive counterfeit drugs would be less common. Perhaps some of the drugs we take would help us, rather than hurt us. If you can't a responsible and responsive answer to the questions, contact your Congressperson.
My personal experience was that the FDA was totally unresponsive, even when there was a serious basis to believe that I had been provided with an inactive counterfeit drug. And by the way, the local branch of the chain pharmacy hadn't a clue to what was going on and had no interest in helping me find out when I returned the suspect drug to them.
But what about the drugs you get from your local or mail order pharmacy? Aren't those drugs certain to be the genuine branded product or a generic bioequivalent?
If you attended law school, the police academy, are a regular viewer of one of the CSI series programs, or if you work for the United States Postal Service handling "Registered Mail" you have probably heard about the "chain of evidence" or "chain of custody." You know that for the chain to be valid, there must be specific contemporaneous written documentation of custody and transfer of custody at each and every step during which it is handled. You might make the assumption that there is a similar chain of evidence for the drugs delivered to you by your pharmacy (local or mail order) in accordance with your doctors' prescriptions. Sorry, this isn't CSI, law school, the Post Office, or a courtroom. If you want to see a puzzled, annoyed, look on your pharmacist's face, ask if he or she knows (and how he or she knows) where and by whom the drug sold to you was produced, whether there is documentation of each step and party in the distribution process, that the drugs you received were actually delivered and received by intermediate parties in the very same sealed containers as they were delivered in, and whether the pharmacist can guarantee that the drug that the pharmacy delivers to you is the genuine branded product or a bioequivalent generic. Unfortunately, our prescription drugs have been commoditized, and the handlers anonymized, so that our faith in the products we receive may be unfounded.
If enough people asked the questions I described, perhaps the distribution process would become transparent instead of opaque. Perhaps instances of expensive counterfeit drugs would be less common. Perhaps some of the drugs we take would help us, rather than hurt us. If you can't a responsible and responsive answer to the questions, contact your Congressperson.
My personal experience was that the FDA was totally unresponsive, even when there was a serious basis to believe that I had been provided with an inactive counterfeit drug. And by the way, the local branch of the chain pharmacy hadn't a clue to what was going on and had no interest in helping me find out when I returned the suspect drug to them.
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