Bypassing FDA Approval and Bringing Your Product to Market Faster

Although it may seem that products must go through the process of obtaining the U.S. Food and Drug Administration’s (FDA)  approval to be considered safe for consumers, there are certain cases in which products can go directly to market without ever needing to be reviewed by the FDA.  The reasoning behind this is that the FDA wants to balance innovation against safety, and permit innovative products to be able to reach the market. The FDA also might allow products to skip the approval process if they are duplicates of another product that has already been approved, or if they are part of the practice already and the observable risks remain minimal.  

Dietary Supplements and Alternative Pathways

One type of product not subject to FDA approval is dietary supplements, which have been ruled by Congress as being a food rather than a drug.  As long as supplements do not make drug-like claims, such as purporting that they treat heart disease, they are not regulated like drugs and their marketing is not regulated by the FDA, but is instead regulated by the FTC.  This means that dietary supplements can reach market much faster than their drug counterparts, however, this also means a higher amount of competition because the market is oversaturated with competing supplements. Although the dietary supplement market is large and highly profitable, the amount of competing players in the marketplace makes alternative pathways to market more enticing.  

OTC Drugs

One of these other options includes the marketing and sale of OTC drugs. OTC drugs can come onto the market using the New Drug Application (NDA) pathway, or the OTC monograph pathway.   The OTC monograph pathway does not require FDA approval, and instead offers a way for drugs to reach the public much more quickly.  As long as companies meet conditions and make specific claims that match those listed on the FDA’s product list, companies are allowed to bring their product to market without FDA approval through this pathway.

Compounding Pharmacies

Yet another method of bringing products directly to market is through the use of compounding pharmacies. Compounding pharmacies do not need to notify the FDA about what specific products they are making until after the products have been brought to market.  One of the reasons why compounding pharmacies remain unregulated is because they function as a sort of “safety valve” in case of accidental shortages in certain kinds of medication, and as a consequence, the drugs produced by these pharmacies are able to reach the marketplace at a much faster rate.  Although these pharmacies are an expedient way to quickly get drugs to market, they do come with their shortcomings–including the fact that they are regulated by state boards of pharmacy, and require the oversight of a pharmacist. Recent FDA inspections have also revealed problematic findings in these types of facilities, which brings these pharmacies closer under FDA observation.  

510(k) Pathway

In the case of the 510(k) pathway, a given company must demonstrate a product’s likeness to another FDA-approved, legally marketed device (or a predicate device).  Certain products are able to bypass this pathway altogether, and put their product on the market directly. These products include devices like toothbrushes and certain cannabis-based products which are 510(k) exempt and do not need to gain FDA approval.  Although the gains are significant for these products, such as the chance to tap into a massive market, there are also risks associated with not gaining FDA approval–particularly for products like cannabis. Although a certain cannabis product may be legal at the state level, it is still considered illegal at the federal level, and therefore might face penalties for non-compliance.  

Conclusion

As the FDA puts out a steady stream of new information on how they want products to be regulated, it becomes crucial for companies to ensure that they stay on top of the new regulatory laws so that their products are able to successfully come to market. 

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The opinions stated in this blog are the sole and present opinions of the blogger and do not necessarily represent the opinions of the Kulkarni Law Firm, PC and/or its attorneys. Such opinion(s) may change over time. Such opinion(s) should not necessarily be attributed to the institution for which these individuals may work or otherwise represent in any capacity. These blogs do not constitute legal advice and should not be construed as such.