There are forces infinitely greater than puny humans who have chosen the darkness of evil, God and His will is always supreme.
freepmail to get on/off this night time ping list
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.
***
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.
***
So there is no simple answer given the complexity of the current market.
freepmail to get on/off this night time ping list
'Complex' due in part at least to an ocean of lawyers and a sea of corrupt politicians... and where is China in all that you posted?
Even generic prices are rising on some products, rising noticeably. Where is the competition? Where the outcry?
Mark