Market access: figuring out the FDA

Seeking approval from the US Food and Drug Administration can be complex and painfully slow. Alan Minsk offers tips to make the process simpler, quicker, and more efficient.



Seeking approval from the US Food and Drug Administration can be complex and painfully slow. Alan Minsk offers tips to make the process simpler, quicker, and more efficient.



Companies that make drugs or medical devices face a big hurdle in bringing their products to the U.S. marketthe Food and Drug Administration (FDA).


Young companies and foreign-based companies, in particular, can find the FDA review process puzzling and agonizingly slow. It does not have to be that way.


A company seeking FDA approval can ease the pain by looking critically at its product and doing its homework to prepare a quality application. That includes figuring out how the FDA thinks.


Keep it simple


In more than 18 years of representing life sciences businesses, Ive learned that applicants help themselves immensely when they are well informed and have the right mindset.


Often, its best to avoid bold marketing claims that will necessitate clinical data, and instead measure success in small steps. Keep it simple.


The FDAs primary focus is product safety, so its easy for the agency to say no or maybe, followed by a request for more information.


Thus, its critical to evaluate questions like, what were the safety issues previous products faced and how were those issues resolved?


The FDA is not terribly concerned with how long a review will take or the applicants expenses.


A companys size, location and economic prospects are of little importance to the agency.


Beware of added value


The FDA is seen as being exceedingly cautious because it fears making a mistake that could pose a health risk.


Therefore, if an applicants product is very similar to one thats already approved, the FDA might ask, why authorize the new product?


If the company then points out the added value of its product, the FDA might respond by demanding more data to back up the claims, a time-consuming and costly step.


The review process can be maddening for companies not used to dealing with U.S. government healthcare oversight.


But it would be a mistake to grow angry and argumentative. No product is perfect.


Listen respectfully, accept criticism, and use it to your advantage.


Turn the FDAs concerns into an opportunity to regroup and make adjustments before too much time has elapsed.


Establish credibility and rapport


A company should work to establish credibility and rapport with a government reviewer in order to have candid, productive discussions.


This starts with informal dialogue between a companys regulatory expert and an FDA review division project manager.


Solid preparation means becoming familiar with the law and the FDAs stance on similar products, if appropriate.


Understand the difference between an agency requirement and a guideline or request, and know when a request is essentially a requirement.


Some review divisions discourage e-mail correspondence and take a more formal approach, preferring meetings, which typically slows the process.


Invest in consultants who are familiar with the division that is going to review the product.


Do your homework


Its amazing how many times early-stage companies do not listen carefully to the FDA or read its correspondence.


They will request meetings with the FDA to address simple questions that should have been answered when preparing for the application.


A successful meeting tackles complex issues and results in a game plan and a better understanding of the FDAs expectations.


For those companies seeking fast-track approval or authorization of an orphan drug, first determine whether the product meets the requirements.


Second, review whether there is existing information that can negate or streamline the need for additional data, reducing expenses and possible delays.


Applicant as instructor


The FDA acknowledges that it does not know everything about every product, so the applicant may have to be an instructor.


At times, its appropriate for the company to push back, but that decision must be made carefully, without emotion.


Conversely, the agency may have more experience with a product type than a company realizes, so dont scoff at questions that seem off base.


The FDA may be doing the company a favor by identifying a potential risk the company did not see.


In summary, dealing with the FDA is a bit like a chess game: The applicant anticipates how the agency will react based on past performance, and then makes its moves accordingly.


Alan Minsk is a partner at the law firm Arnall Golden Gregory LLP in Atlanta, Georgia, where he leads the Food and Drug Practice Team. Mr. Minsk advises pharmaceutical, biological, medical device and food companies on all legal and regulatory matters relating to the U.S. Food and Drug Administration and the Drug Enforcement Administration.


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