"Just Make A Generic (Cheaper Version) Of The Drug"? Not So Easy...

Source: Kansas City Business Journal

The cost of prescription medications is among the most contested political issues right up there with the associated cost of health insurance.  Anytime health insurance is mentioned, just wait -- a discussion is about to unfold linking that to the cost of prescription medications.  Why are medicines so expensive?  Simple answer: the cost of bringing a new drug to market is around $1 billion along with around 20 years of research/approval process.  What?  Yes.  If you happen to have $1 billion laying around, then you too can create a new medication.  Well, not really.  But in theory (based only on cost).



With this being known, why are generic medications cheaper?  Further, why are generic medications not sought out sooner (i.e. released to marketplace sooner)?  The answer to the second question is that the first medication (the expensive) one has 'ownership rights' -- patent rights -- for a given number of years.  As to why after the patent expires, the generic medication cannot be rolled out sooner -- ask the Food and Drug Administration commissioner.  FDA Commissioner just resigned.  Although, before he resigned, he managed among other many changes to leave a public statement regarding the status of expanding access to generic medications.  Included in the statement are the reasons/parameters which are considered or serve as obstacles to the roll-out of generic medications.  These considerations might clarify for the public the complicated generic drug landscape.



Below is the statement taken from the FDA website on expansion of 'generic medications' into the marketplace:

As part of the FDA’s efforts to promote drug competition and patient access, we’ve advanced many policies aimed at making it more efficient to bring generic competition to the market. We’ve been especially focused on a category of medicines known as complex drugs. These are drugs that, by nature of their formulation, delivery systems or the complexity of their active ingredients, for example, are harder to “genericize” under traditional approaches. As a result, these complex drugs often face less competition.

As a category, there are a number of complex drugs that are no longer protected by patents or exclusivities that would forestall generic approval, yet they continue to face no generic competition owing to the difficulty of developing generics. The agency has advanced many new policies to help promote generic competition to complex medicines once patents and exclusivities have lapsed, and we’re planning additional policy steps in 2019.

To understand the challenges posed by complex generics, we need to go back to the pathway developed in 1984 under the Hatch-Waxman Amendments. This legislation put into place the framework for generic drug review at a time when brand drugs were often simple small molecules requiring straightforward and reproducible manufacturing processes. They were generally easy to characterize and evaluate through traditional methods, including human bioequivalence studies. In many cases, a drug’s activity correlated directly with how quickly it got into the bloodstream and how long the drug stayed in the body, so it could have its intended effect on the anticipated site of action.

In contrast, complex drugs involve cases where the drug is often harder to develop and manufacture because it has a complex formulation or complex active ingredient. In other cases, the drug acts locally on the tissue rather than through the concentration in the blood. This includes, for example, inhaled drugs that act directly on the lungs, a topical patch that is activated directly on the skin, or eye drops that act on the surface of the eyes. The therapeutic effect of these types of drugs does not necessarily correlate directly to the amount of drug in the blood, or it can be difficult to measure through the blood. They can raise other issues that make the traditional, metrics generally used to develop generic drugs harder to employ. In other words, it can be more difficult to meet the standards for generic approval.

In 2019, we’ll advance additional policies to promote generic competition for complex drugs. Among other steps, we intend to issue additional guidance documents for developing specific complex generic drugs, as well as address categories of complex drugs that are hard to copy because of their complex formulation or mode of delivery. This will include the publication of a series of guidances to address regulatory and scientific challenges that make it generally more difficult to develop complex generics. As part of this, we intend to issue draft guidance with recommendations on establishing active ingredient sameness. In addition, we’re going to help advance the development of new analytical tools and in vitro tests that may provide additional accurate, sensitive and reproducible tools to support approval of complex generic drugs. Better tools can reduce complex generic drug development time and cost and can inform regulatory decisions.

These are just some of the new steps that we’re going to be taking in 2019 to promote access to complex generic medicines.

These new policy efforts are aimed at ensuring that we provide as much scientific and regulatory clarity as possible with respect to complex generic drugs. This focus is critical because, first and foremost, these drug products provide important therapies to patients. We believe that they’re also becoming increasingly important to the economic stability of the generic drug industry. Being able to “genericize” a complex medicine can be a high-value opportunity for a generic drug developer.

Addressing the challenges related to complex generics, and promoting more generic competition to these medicines, is a key part of our Drug Competition Action Plan, and the agency’s efforts to promote patient access and more affordable medicines.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

The generic drug approval process seems to have changed over the last few decades with the development of new types of medications.  Traditional routes of administration have changed.  Which is to say, become much more specific (precision medicine).  This change has caused an uproar among approval authority.  Old medicines use old approval processes.  New medicines require new approval processes.  Precision medicine will ultimately speed up the approval process by causing federal agencies such as the Food and Drug Administration (FDA) along with the National Institutes of Health (NIH) and the Department of Health and Human Services (HHS) to update review/approval/funding processes.



Currently, these changes are under consideration by federal agencies.  Recently, FDA Commissioner Scott Gottlieb gave an outgoing interview with the journal 'Politico' -- which is embedded below:





Ultimately, the new landscape brought about by changes in medicine along with the collection of medical data (All of Us - NIH trial) will result in better medical practices for the public.  Stay tuned, the future is exciting.





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