There is a little problem with the safety rating that is being given to generic medications. The more sensitive population, who is in need of precise and careful care by their physician, is not being represented safely by the FDA rating. While generic medication has good result for most, that is not the case for every person.
The 20 percent delivery difference of active ingredients that the FDA allows in generics, is necessary because the inactive ingredients vary as compared to the brand medication counter part. The different fillers in generics do affect how a sensitive person - such as; allergy prone, immune deficient or known atypical metabolizer - will respond to the delivery of the active ingredients in the generic.
There is a diagnostic that identifies atypical metabolizers. Poor metabolizers of the 2D6 enzyme do not respond typically to many medications, as far as how the medications will deliver in the system. Those who are poor metabolizers will likely be prone to side effects, sometimes dangerous ones that are more than slightly adverse as far as health and safety. Generic medication will confound things in cases where the fillers have possibility of change from month to month.
The FDA represents that it simply provides a safety rating for the generic; it feels resulting problems from the rating are not the fault of the FDA. In order to achieve a successful FDA safety rating, the generic is only required to be tested on normal subjects. Evaluation of how generics affect the more sensitive population is not required by the FDA. There is not a specific reporting program in place in order that insurance might be required to report adverse affects from use of generics - when those who are covered by them accept the forced switch from brand to generic, and then have to go back to brand due to adverse health affects from the switch.
Insurance companies allude to the FDA rating, in order to insist that even atypical responders make a switch to generic. The FDA allows this and does not address the problem that their safe and equivalent rating is causing. The FDA represents that it does not regulate the practice of medicine - but only the safety rating on generics. The FDA seems to be regulating the practice of medicine if, in fact, the insurance companies are using the rating as medical fact across all types of illnesses...even with medical cases where the rating of equivalency should never be applied. There can be a dramatic difference in response between brand and generic medication, for those who have health issues or sensitivity - which means brand medication and the generic counter parts are two entirely different medications for such people.
Due to the allowed 20% difference in delivery of the active ingredient, and the use of different fillers, generic and brand are altogether different medications for many who desperately need the same delivery of their medication, every time. While brand medications have the same ingredients every time, generics medication counterparts have fillers that could possibly differ every month, according to how the pharmacy is supplied - and therefore the delivery of the needed active ingredient will differ according to the difference in filler for those who have sensitivity in response.
The Generic Difference is in the...Active ingredients, bulking agents, preservatives, coatings, shelf life instabilities, manufacturer glitches. (Susan Okie, M.D., Multinational Medicines-Ensuring Drug Quality in an Era of Global Manufacturing, 8/2009)
The process of regulating generic medications has actually gone a little backward. "Before 1984, generic-drug makers were obliged to conduct the same safety and efficacy tests that had been required of the original brand-name manufacturers to receive Food and Drug Administration (FDA) approval for marketing." (Additionally): The Hatch-Waxman Act allowed abbreviated process for generic drugs to receive FDA approval and allowed generic drug manufacturers to apply for FDA approval and conduct tests before relevant patents expired. Furthermore: Companies seeking approval of generic drug are not required to conduct chemical trials of its safety or efficacy, but most submit results of a study in healthy volunteers with product absorption comparative to brand - medication counter part. (Richard G. Frank, Ph.D. "The Ongoing Regulation of Generic Drugs" 11/2007)
Generic companies actually seek competitive edge...
"There is also intense price competition among generic products. Generic-drug manufacturers have sought ways of gaining some competitive advantage over their rivals so as to be able to raise prices. One approach was to forge exclusive relationships with producers of the drug's active ingredients, preventing rivals from being able to supply the market. These arrangements were found by the Federal Trade Commission (FTC) to violate antitrust law, and antitrust authorities continue to monitor the conduct of generic-drug manufacturers closely." (Richard G. Frank, Ph.D.) *Information source comes from New England Journal of Medicine.
Here is a little bit about how much the active ingredient really costs - according to Sharon L. Davis, Budget Analyst U.S.:
...Since the cost of prescription drugs is so outrageous, I thought everyone should know about this. It pays to shop around! This helps to solve the mystery as to why they can afford to put a Walgreen's on every corner. On Monday night, Steve Wilson, an investigative reporter for Channel 7 News in Detroit , did a story on generic drug prices gouging by pharmacies. He found in his investigation that some of these generic drugs were marked up as much as 3,000% or more. So often we blame the drug companies for the high cost of drugs, and usually rightfully so. But in this case, the fault clearly lies with the pharmacies themselves. For example if you had to buy a prescription drug, and bought the name brand, you might pay $100 for 100 pills......I used the generic equivalent, which cost $54.99 for 60 pills at CVS. I checked the price at Costco, and I could have bought 100 pills for $19.89. For 145 of my pain pills, I paid $72.57. I could have got 150 at Costco for $28.08.I would like to mention, that although Costco is a 'membership' type store, you do NOT have to be a member to buy prescriptions there as it is a federally regulated substance. You just tell them at the door that you wish to use the pharmacy, and they will let you in.I am asking each of you to please help me by copying this letter, and passing it into your own e-mail, and send it to everyone you know with an e-mail address.
Sharon L. Davis BudgetAnalyst U.S.
Department of Commerce
I do have a personal interest in this is because my daughter needed to stay on the brand version of a medication due to medical necessity, since she is a poor metabolizer of the 2D6 enzyme and there were many years of refractory response to medications before we finally found what would work for her. Insurance makes exception for those on narrow therapeutic index medications; drugs that require blood work in order to satisfy proper dosage requirements. I finally was able to show insurance that every medication should be considered narrow therapeutic index for my daughter due to her refractory psychosis (schizophrenia like) and her issue of poor metabolizing. She would have had to have been admitted to the unit for a switch to generic, and we would have had to adjust another medication (lithium) that she was on if we switched to generic version of the fought about medication.
It took almost a year to convince the insurance company. They denied several appeals by both myself and some government agencies...and then I called the insurance company and told them that I was " ...a momma bear that wasn't going to go away and I have a lawyer who thinks my case has strong points, but I don't want to go to court". I actually begged quite a bit too. The insurance company then reviewed her health history in earnest, and allowed continued use of brand medication due to medical necessity. Quite a switch from what I was initially told by customer service at the start...
1) Don't bother appealing because you won't prevail.
2) Another person in customer service told me she had appealed, lost and her child was back in 'the unit'.
3) A couple representatives told me that the contract was on their side, and I shouldn't be expecting an exception that was outside of the contract.
4) My daughter's doctor was even refused the opportunity to present the medical necessity of keeping my daughter on brand. The pharmacy benefits professional told the doctor that there was no basis for appeal because generic had been approved as having the same therapeutic value by the FDA; and the insurance contract had a tier principal that automatically switches pharmaceutical benefit upon FDA approval..reducing the benefit for the brand medication. In Sarah's case it meant that I would have to pay about $417 a month, instead of $40.
5) There were at least two representatives that made sure I understood the process for appeal, and I should pursue it.
People's Pharmacy provides multiple years' worth of reports of adverse response to generic by people who had been successfully treated with brand named medication, but forced to switch to generic.
I used to look over a CrazyMed site years ago, and was overwhelmed by the posters' necessity to experiment with the generic medication they were forced to switch to, from other medications that had given efficacious results.
There can also be significant change in response in a switch from one generic brand to a different generic brand. Yeah, I could not believe that there are actually branded generics now - which is what the lithium my daughter was on became when a new generic lithium was approved. Our pharmacy gave my daughter a different generic version of lithium recently and I tried to explain that they shouldn't do that because the fillers are different - even from generic to generic - and lithium is a narrow therapuetic index medication. It took a while to straighten out, but eventually insurance confirmed what I told the pharmacy.
Everyone talks about saving at the pharmacy, but I guarantee you some people who have been inclined to switch to generic have problems and are needing to visit the doctor more frequently, perhaps needing more inpatient stays - and I am just going to say that I wonder how many might have done themselves in due to the psychosis that revisits them while experimenting with generics that don't give the same results. Generics are not saving money, given that kind of scenario.