The FDA, the USPTO and the Pharmaceutical Industry

The FDA, the USPTO and the Pharmaceutical Industry 

There is enough evidence for one to be very suspicious relative to the relationship between the FDA, the USPTO (Patent Office) and the Pharmaceutical industry. One can only imagine how much money from the Pharmaceutical industry is influencing the FDA’s and USPTO’s decisions. But don’t take my word for it, just Google “collusion between the FDA and the Pharmaceutical industry”.

There are instances where the FDA has approved either human drugs or animal feeds that never should have been approved and there are allegations of collusion. There’s the fast tracking of drugs whose data doesn’t support approval. And more. I won’t repeat all of the concerns here. You can look those up.

The ones that irk me the most are:

  1. Allowing the same drug to be re-marketed as a new drug when it isn’t.
  2. Strongly supporting discarding all drugs according to an expiration date supplied by the manufacturer when studies show the expiration dates can be as long as 10-20 years.

All of the above result in Pharma making astronomical profits for no reason.

Remember, it’s all about the money.

Let’s look at these.

Allowing the same drug to be re-marketed as a new drug when it isn’t.

I’ve mentioned this one before. To recap, often, when a drug is synthesized it is a blend of two “isomers”. This means that the manufacturing process creates the exact same molecule except that the arrangement of the atoms in the molecule form in a right or left-handed arrangement. Test this out yourself. Hold up both of your hands. They both have a palm and five fingers and look the same except one has the thumb on the right and one has the thumb on the left, with the other fingers following suit. Your hands are “isomers”. They both do the same thing, they are just mirror images of each other.

Well, drugs do this, too. The mixture of the two isomers is called a racemic mixture. Depending on which naming method a company uses, the drug has R (rectus/right) or L (levo/left)or D (dextro/right) or S (sinister/left) isomers.

One major fact with most drugs is, one “hand” is often active and the other is inactive, whereas both your hands are active unless you had an accident, stroke or congenital anomaly. If you remove the inactive 50% (isomer), you only have to take ½ of the milligrams of the dose of the racemic mixture. It’s just third grade math.

Instead of the FDA and the USPTO having a rule that the drug company should submit the approval for the drug based on its active isomer, the FDA and USPTO approves the racemic mixture with exclusivity rights. The FDA and USPTO should reject the second applications for the active-isomer-only on the basis that the drug is not new, just “filtered” or “sorted”.

This goes hand in hand with patenting. A drug company gets a patent for the racemic mixture for 14 years. Then, as the patent is running out, the drug company separates the two isomers and the USPTO approves the active isomer as a new drug, giving the drug company another exclusivity period and the ability to call it something different and it is now a “new brand drug” for 14 more years! I wonder how much money changed hands there! Maybe they need an inservice from a PharmD!

With this new FDA and USPTO approval, the drug company can now legally market the drug as a new drug exclusively. And charge prices that are up to 10 times the cost of the drug going off patent and now called generic, even though it is the same drug.

The biggest offender is Nexium. Read about that in my first Pharmaceutical Industry post.

The latest is Xyzal. There’s an ad about it 2-3 times an hour on TV. It’s drug name is levocetirizine. It is the left-hand isomer of cetirizine which is Zyrtec. Heard of that? Thirty-five Xyzal at Walmart costs $17.96 or 51 cents a tablet. You can get 180 cetirizine at Walmart for $29.86 or 17 cents a tablet. The only difference is….the dose. Cetirizine/Zyrtec is 10 mg and Xyzal is 5 mg. Exactly as you would predict. Same drug, three times the cost. And people will buy it because they don’t know it is the same drug, they think it is new and “better” because that’s what the ad is saying. Terrible!!!

This should never be allowed. It’s a total rip off of the US population. Here’s some another examples.

Back before 2013, inhalers for Asthma and Chronic Obstructive Pulmonary Diseases (COPD) had CFC’s (Chlorofluorocarbons) as the propellant in them. These are inert and don’t affect the actual drug performance. They affect the ozone layer, so they were banned. CFC’s just push the drug out. Almost all of the CFC inhalers were generic and cost about $15 per canister.

After Dec 31 2013, the propellant had to be non-CFC. The drug companies switched the propellant to HFA’s (Hydrofluoroalkanes). Folks, this is merely the gas used to push the drug out of the canister! The FDA and USPTO allowed the drug companies to call these inhalers “new”, meaning they were again “branded” drugs with exclusivity. This allowed the drug companies to charge $30-45 a canister. The “generic” market completely disappeared because the CFC’s were banned. People with Asthma and COPD now either had to pay 2-3 times what they were paying or, if they had drug coverage with their insurance, they had to pay the “brand” co-pay, which generally went from $10 per canister to, generally, $40 per canister, a four-fold increase!! Overnight! Guess who made a lot of MONEY? Same active drug in the canister. 3-4 times the revenue for the drug company. Really? How does a propellant change warrant a 40 year old drug now becoming brand name again? For 14 years?

This should never be allowed. It’s a total rip off of the US population.

Expiration dates on drugs.

This is a sacred cow subject. As you all know, there is an expiration date stamped on every bottle of medications.

The USP says that the expiration date is “the time during which the article may be expected to meet the requirements of the pharmacopial monograph provided it is kept under the prescribed conditions.”

The dates are usually 1-3 years from the time of manufacture. This doesn’t mean that the day after the expiration date the drug is no good or is toxic. As a matter of fact, the vast majority of drugs in tablet form are good for ten or more years after manufacture. Using 1-3 years instead of 10-15 gives the drug company freedom from any liability due to a legal challenge of inadequate potency. Studies done by the US government and private research show that most drugs still have >90% of their potency after 10-20 years, depending on the study length. Interestingly, the drug companies themselves don’t test the potency of their drugs over time! Guess why? If they did and they determined their drugs were still clinically potent enough after 20 years, they would…guess what…MAKE LESS MONEY! (Remember, it’s all about the money)

I mean, really, how old are the major drug companies?:

Bayer founded 1863

Merck 1891

Pfizer 1849

Schering-Plow 1851

Bristol-Myer Squibb 1887

SmithKline 1715

Beecham 1842

Lilly 1876

Are you getting the picture?

You mean these companies couldn’t put a case or two of each of their medicines in a warehouse somewhere and tested them every 5 years until the potency was so low the drug wouldn’t be therapeutic anymore? Really? Of course not! People would keep their drugs longer and the drug company WOULD MAKE LESS MONEY!

And, the FDA is very adamant that no one should take any medication beyond its expiration date, even though they must know the literature on this. They’ve developed “take-back” programs and scare the bejesus out of the general public into throwing their drugs away.

The available research data supports expiration dates farther into the future than any drug company determines. And, except for one form of tetracycline from 1963 which is no longer on the market, there are no reports of a drug “going toxic”, which the FDA also proposes can be the case.

So what’s going on? Well, the FDA is, first, covering its ass. Secondly, they are promoting discarding and destroying perfectly good drugs so drug companies can make as much money as possible. In the hospitals I worked at, in the nurses’ med rooms, there are these big flushing sinks where the nurses would purge expired drugs. The cost to the global population is huge. Of course, the drug companies are MAKING A TON OF MONEY because of this. (Remember, it’s all about the money)

A USA Today article cited that we throw away about 250 million pounds of drugs a year because they “expire”.

Now, there are some drugs you don’t want to take after their expiration dates. Some degrade quickly. These are mostly drugs in liquid form, like epinephrine, certain IV antibiotic drugs or drugs that have to be reconstituted from a powder. Insulin is another one.

Another category is drugs with narrow therapeutic indices or unique handling in the body. For example, if you have to have a blood test to measure the levels of a drug in your body, you shouldn’t take these after their expiration date. Not because it definitely isn’t good anymore, it’s because the drug company hasn’t tested its degradation rate and you don’t know. And even a 10% reduction in a drug like Dilantin (for seizures) or digoxin (for heart problems) or warfarin (Coumadin) (for blood thinning) could get you in trouble.

So, this issue is clearly due to the Pharmaceutical industry refusing to do these studies so people know the truth. And the FDA doesn’t mandate that the drug company needs to provide that data. They should, as part of the approval process, mandate potency and, I guess, toxicity testing for at least 20 years from the initial manufacture date, i.e., the first couple of cases of the drug should be saved and tested. But, Noooo! Let’s just throw the stuff out so the drug companies make money from providers and patients disposing of and re-buying drugs to sustain the drug companis’ double-digit profits.

After all, it’s all about the money, not the truth.

Addendum September 21, 2017: So, if you think this is just me ranting here’s a reference for you backing up whatever I’ve written in this blog-site. “Strategies That Delay Market Entry of Generic Drugs”, Kerstin Noëlle Vokinger,MD, JD, et al; JAMA Internal Medicine Published online September 18, 2017. Pretty much saying the same things I am, but more eloquently. The FDA and USPTO facilitates Pharma making as much money as possible.