||Jan 05, 2021|| Barry Sherman, 75, the founder and chairman of the board of generic drug giant Apotex, and his 70-year-old wife, Honey, were found dead in the basement pool area of their home on Old Colony Rd. in Toronto's North York neighbourhood on Dec. 15, 2017***
My interest in this murder story is purely speculative and circumstantial... still, it addresses possible motive and subsequent consequence.
China is now the major supplier of prescription drugs in the Western Hemisphere. Lately China has been taking advantage of that situation by hiking the price on some drugs. Even some generics that have been around for decades and selling for pennies a dose have risen to alarming proportions.
Under such circumstances, competition is the obvious reaction to potential price gouging. Competition for proprietary drugs is not tenable since they are protected by international patent agreements. However, for generic drugs, the market is the wild wild west. If one generic manufacturer decides to suddenly hike it's profits through price gouging, it is a simple matter for another generic manufacturer to offer a cheaper generic alternative.
Likewise, when a proprietary drug loses its patent and license protection, it is common for generic drug companies to experiment with cheaper alternatives for sale. Such generic offerings are protected by governments through quality testing and licensing arrangements in order to protect the consuming public.
Take one example of the latter situation. A long acting injectable insulin - let's call it Rampus - has lost its proprietary status; it has sold for approximately $370 for a 30 day refill. A generic drug manufacturer estimates that it can produce a duplicate product - and pass government quality test standards - for $45 for a nominal 30 day supply. If the competitive drug is allowed on the market, it drives the market price down.
A powerful drug supplier with firm political connections might seek to squash the emergence of competitive generic products. If the insulin Rampus is two or three years out of patent protection, one might speculate what forces are preventing the emergence of generic competition. Could it be government corruption in not allowing approval of generic drug production? Or could other, more nefarious, forces be at play?
https://www.youtube.com/watch?v=2uJdrQ6I2Y0
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Mark
Improperly Issued Brand Name Drug Patents Can Cause a Delay in Generic Drug Entry Into the Market:
...Improperly issued drug patents can and do delay the entry of generic drugs. Indeed, a key strategy of brand-name pharmaceutical manufacturers is to obtain patents not just for active ingredients, but also for peripheral features such as a drug’s coating, formulation, or delivery mechanism. In a previous study, we showed that two highly profitable active ingredients were covered by scores of patents. In some cases, these patents may be obtained after FDA approval of the original drug product (though usually based on patent applications filed prior to drug approval) and extend many years in the future at the time the patent on the active ingredient expires and generics are ready to enter the market. As a result, manufacturers of generics frequently must challenge brand-name drug patents in court to sell their products in the US.
To address such improperly issued patents, the 1984 Hatch-Waxman Act created a framework that encouraged manufacturers of generic drugs to challenge brand-name patents in court. In the 1990s and 2000s, generic manufacturers prevailed in challenges of method-of-use and formulation patents between 33 percent and 71 percent of the time. But even an ultimately successful court challenge can entail a protracted legal battle that can delay timely entry of a generic, or even deter entry entirely. Moreover, the Hatch-Waxman Act provides that when patents are listed in the FDA’s “Approved Drug Products with Therapeutic Equivalence Evaluations” (commonly known as the “Orange Book”), a lawsuit initiated within 45 days by a brand-name manufacturer triggers a 30-month stay of FDA approval of the generic product, delaying generic market entry by two-and-a-half years or until the litigation resolves, whichever occurs sooner.
https://www.healthaffairs.org/do/10.1377/hblog20200827.532806/full/
Strategies That Delay Market Entry of Generic Drugs
...Although generic competition helps lower drug prices, manufacturers of brand-name drugs often work to delay the availability of generic versions of their products. Strategies to forestall generic competition include patenting peripheral aspects of a drug or modified formulations that do not add clinical value, paying generic manufacturers to settle lawsuits challenging the validity of patents on brand-name drugs (“reverse payment” settlements), denying generic manufacturers access to drug samples necessary for bioequivalence testing, misusing risk evaluation and mitigation strategies, and filing citizen petitions with the US Food and Drug Administration (FDA).
Also Pharmacy Benefit Managers effect both the name brand drugs and the generic drugs in the market.
So, just who are ‘Pharmacy Benefit Managers’ or ‘PBM’s as they’re more commonly known.
They’re the quiet middlemen that stand between drug manufacturers and your local pharmacy and even though you’ve never heard of them, they know all about YOU.
Pharmacy Benefit Managers were originally created to assist the healthcare industry by acting as a liaison between parties and administering costs and procedures that actually helped everyone.
But over the years they have morphed into a super powerful group of organizations that now dictate how much YOU as a consumer pay for your prescription drugs.
And it doesn’t end there.
PBM’s claim to work for health insurers to get lower-cost drugs from the drug manufacturers but they also claim that drug manufacturers alone set drug-prices
But here’s the reality, according to a study by the IQVIA Institute for Human Data Science, PBM rebates charged to drug manufacturers in 2019 amount to $143 billion, which added nearly 30 cents per dollar to the price you pay for your prescription drugs.
And to make matters worse, the three largest PBM companies in the US control a staggering 76% of all the prescription drug business in the country.
Meaning the vast majority of American’s are overpaying on their prescriptions every day because of PBM’s.
And it doesn’t stop there.
Because the PBM’s also control where you get your prescription drugs as well.
One of the three largest PBM’s in the country is CVS Caremark, which is owned by the CVS Pharmacy Group.
CVS Caremark not only sets drug prices but determines which pharmacies are in their network and the amount that pharmacies will be reimbursed for a prescription.
Doesn’t sound so bad, until you realize that your local independent pharmacy may not be in the PBM’s ‘preferred pharmacy network’ which means that, although you can still get your prescription drugs from your local pharmacy, you could end up paying more for your prescriptions drugs through your co-pay and the local pharmacy receives less reimbursement from the PBM because of restrictive ‘take it or leave it’ contracts.
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The Hart-Waxman Act also probably needs to be updated for today’s complex market. I remember during Trump’s first term a generic company stated that FDA red tape was preventing it from bringing a generic insulin to market . Plus if the brand name is a biologic drug like insulin it is more complex to produce a generic than say for synthroid.
Another hurdle has been the FDA’s approval process for biosimilars and follow-ons, which is more elaborate and demanding than the process used to approve simpler generic medications. That’s true even though Congress created an “abbreviated approval pathway” in 2009 when it passed the Biologics Price Competition and Innovation ActTrusted Source.
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So there is no simple answer given the complexity of the current market.
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