Posted on 12/16/2017 9:57:30 PM PST by Oshkalaboomboom
Both Republican and Democratic senators have criticized moves by drug makers to extend the life of their monopolies on sales. But action on high drug prices, a major concern for consumers, has been so far negligible in this Congress.
Senators on the Senate Health, Education, Labor, and Pensions Committee complained during a hearing earlier this week about drug makers that game the system. There was also criticism from Democrats about President Trump’s pick to lead Health and Human Services: Alex Azar, who led the U.S. division of Eli Lilly, a pharmaceutical company.
Drug makers have used a technique called evergreening to extend the life of a patent for a brand-name drug.
Sen. Patty Murray, D-Wash., lashed out that “companies are systematically continuing to layer new patents on old drugs to keep competitors off the market.”
Some of her Republican colleagues joined the criticism.
“An obstacle is what is called the patent thicket strategy that too many drug companies pursue,” said Sen. Susan Collins, R-Maine. “Humira, which is the best-selling drug in the world with $16 billion in annual sales, does not have a generic equivalent because its manufacturer has obtained more than 100 patents with various changes to block generic companies from coming to the market.”
When the Food and Drug Administration approves a new drug, it gives the manufacturer 17 years of sales exclusivity. After that time is up, then a generic drug maker can make and sell a cheaper version of the product.
However, a drug maker can get a new patent for a slight modification for a product, and effectively get a new patent.
“What you do is you keep coming up with a slightly different population that needs the drug,” said Gerard Anderson, a professor at the Johns Hopkins Bloomberg School of Public Health. “It is not about cancer, it is about breast cancer but breast cancer with this condition or that condition in addition to the breast cancer.”
Technically, a generic drug maker can still make a cheaper version of the original drug, but it cannot make a version of the newer drug with a slight modification.
“If you are a hospital you only want to have one drug on your formulary,” Anderson said. “You don’t want to give the wrong drug to the wrong person so it is easier to have just one drug on formulary as opposed to two.”
He added that a hospital usually only buys one drug due to safety concerns, to make it easier to ensure the wrong person does not get the wrong drug. So a hospital would likely go more for the newer version.
Some drugs for rare diseases, also called orphan drugs, can have 10 or more applications. Some of the applications are part of a focus on personalized medicine, which is an initiative to tailor medications to a patient.
Anderson said that any solution to evergreening would require new legislation, not regulatory moves. Legislation concerning patents and generic drugs was last passed in 1984 as the Hatch-Waxman Act.
“In 1984 when [Rep. Henry] Waxman and [Sen. Orrin] Hatch put the law together, they never thought of personalized medicine,” he said.
Legislation could target how a patent is structured, which Sen. Rand Paul, R-Ky., alluded to at the hearing.
“I think the evergreening is a big thing and we have to come to a bipartisan agreement where we say where patents end,” he said.
A report from the National Academies of Science and Engineering recommended limiting patents as well. It called for shrinking the market exclusivity on sales for rare disease (orphan) drugs to seven years.
The generic drug and insurance industry are fighting for Congress to clamp down on the practice.
Back in July, America’s Health Insurance Plans testified at a congressional hearing that evergreening does not “typically provide an enhanced clinical benefit to consumers.”
Anderson acknowledged that any legislation to tackle evergreening must draw a fine line to not stifle innovation and prevent drug makers for pursuing such treatments.
“You still want the pharmaceutical industry to innovate and to do clinical testing on that population,” he said. “Otherwise you don’t know if the drug works for that population.”
Congress has taken some measures to combat high drug prices, solely focused on spurring more generic drugs competition. These include allowing the FDA to approve generic drugs faster if there is only one sole source manufacturer of a generic, which can lead to price spikes as no competition can lower prices.
But that legislation was an answer in part to cases such as the infamous price spike orchestrated by former pharma CEO Martin Shkreli. His company, Turing Pharmaceuticals, acquired an antimalarial drug that had been off patent for years called Daraprim. It then raised the price by 5,000 percent from $13 a pill to $750.
Shkreli, later ousted from Turing after being charged and later convicted of securities fraud, was able to raise the price because there was no competition for Daraprim, since drug only served a small population.
If the new drug is just a slightly modified molecule of the original drug it is a new drug and must obtain its status as a new drug with all the clinical trials. Thus they obtain a new patent. The original drug is off patent and can be copied as a generic. This is okay and good. The drugs I take today cost just a few dollars each a month. Years ago they would have been very expensive. Mine are all generic.
One of the real problems with generics is companies will buy the generic manufactures and obtain a monopoly and increase prices beyond belief.
New and novel drugs are expensive as hell and they should be. The profit motive is what makes those in drug research pursue new medications and treatments. Capitalism works! If not for the profit motive these new drugs would never be discovered.
ps
As a young child I almost died due to acute kidney failure. I was save by what at that time was a new drug, in the sulfonamide class. Capitalism saved my life.
cpdiii clinical pharmacist
The problem is the FDA, they make too hard for competitors to come on the market.
If the company spends time/money for a new patent, then they should get one. If the original formulation is available for generic production, I think it’s fair. Unless people want govt to take over R&D for drug development. In that case we would end up with more drugs of abuse than drugs of benefit. Everything they touch turns to crap.
They should streamline the FDA process so that it will be less expensive to make or alter a drug, thus making the continuation of the monopoly less expensive for consumers.
When the Obamacare mandate is dropped, low-cost solutions instead of expensive pharmaceutical poisons will be developed.
Allow reimportation of drugs to eliminate overseas price differentials.
Capitalism will solve the issue from that point.
I now have cancer - a very slow growing form. I strongly oppose ANY more government interference "regulation" of the ability of drug companies to develop new drugs. Believe me, reducing their profits will indeed, reduce their development of new drugs. Then, maybe some day I'll get to bounce a grandchild on my knee.
huge majority of Rx drugs (even those Alzheimer based one delivered to Congress) are not needed if people changed to healthy habits.
“Drugs are extremely expensive to develop.”
Over-regulation doesn’t help.
And this is the fault of the pharmaceutical company how?
That will have the opposite effect of what you are saying. Drug companies must patent drugs in order to protect their investment in drug development. It costs upwards of $2 billion to get a new drug on the market. That's Billion, with a B. It takes a decade, or more, to prove a new drug is "safe and effective" the criteria for FDA approval. That eats up more than half the 20 year patent protection period. Drugs must be priced in order to recoup the $2 billion cost (plus the cost of other drugs that are not approved.)
The actual cost of producing the drug is co close to zero that you can consider it to be zero in comparison with the development cost. The price of the drug is set, then, simply to recover the development and FDA approval costs. Selling to countries that have strictly regulated drug prices is included in that formula That's what you are calling "capitalism". Remember, the production cost can be assumed to be zero. Allowing "reimportation" from these price regulated countries would eliminate that opportunity, and thus would severely limit the development of new drugs.
Yes, and what about the drug company? I know the Left and Millennials hate them like they hate the ISPs (just read about the screaming over Net Neutrality), but without a profit, why in the world should they work on new drugs?
PEOPLE create drug companies, and other people work for them. Do we expect them to work for free, as our slaves?
Innovation is found on getting a reward for the hard thinking and work being done. It takes an enoromous amount of money to buy all the lab equipment, testing and getting FDA trials to test and not kill people in the study. I'll be for every successful drug developed, thousands are duds or too dangerous.
Take way the profits and people just won't do it.
As a reaction victim of MULTIPLE FDA approved drugs, I want better control of what they approve. If a drug causes cancer it should not be approved, nor A-Fib, or thoughts of suicide or is ADDICTIVE. Or other diseases. I read about every drug I’m prescribed, I have to or some would do great harm even cause death. Because some doctor didn’t do their homework and look at my Reaction list or Health List. 1 Trip to the ER for A-Fib and Fosamax for Osteoporosis is on the REACTION list for A-Fib. All OP drugs are listed for A-Fib by the FDA.
There are many FDA approved drug DRs OVER PRESCRIBE besides pain meds, most are like Lyrica, Neurotin, Xanax, Cymbalta all highly addictive. Yet they chose Opioids as the target of the “FAKE OPIOID CRISIS”. FL #1 Addictive drug is XANAX.
As for Generics not ALL are equal to the name brand. Guidelines should be that they are EQUAL. Thyroid generic is 30% less thyroid hormone vs Name Brand. Many drugs effect the effectiveness of Thyroid meds as do so foods.
As for insurance raising prices, what about the REMOVAL of Meds? We are Medicare/Tricare Life as hubby is a 20 yr career Ret. SCPO ALL our healthcare is Government controlled. Nexium was removed from the Formula, 3 others put on, I’m allergic to all 3, not even a letter of need from the GASTRO will provide coverage for the Nexium...not all people can make do on the low dose 20 MG that is not OTC. I take 40 mg, hubby takes two 40 mg. He can move to Prilosec, I can’t. Nexium comes with a Co-pay, it’s not free but Tricare now no longer will cover it at ALL. We both received letters of denial of coverage.
Being seniors on SS limits our income even with his Navy pension, service time was 60-80’s so pension is not that big, nor have we seen many COLA raises or very small ones in the past 8 yrs. And Congress Both parties are trying to cut Medicare. SS.MEDICARE ARE NOT ENTITLEMENTS, but a Pre-Paid TAXES.
This is the same Washington State U.S. Senator, who along with Maria Cantwell, were the deciding votes to deny Americans the right to purchase drugs from Well regulated Countries like Canada. Their excuse was that the safety of drugs from Canada hasn't been established.
I get a Lupron injection every 3-4 months for metastatic prostate cancer. Cost in the U.S. is $5,500 to over $7,000. Go to a Canadian pharmacy and the cost is $1,200 to $1,400.
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