Do You Know the Real Reasons Why FDA Issued an MDO on Your PMTA? Find Out!

We now know that the U.S. Food and Drug Administration’s (FDA) decision-making process to deny thousands of PreMarket Tobacco Product Applications (PMTAs) and issue a formal Marketing Denial Order (MDO) from the FDA was not very transparent. It also appears to not have been very thorough.

Do you even know the real basis of why yours was denied? Want to find out if it was actually based on anything specific?

For those who have received an MDO, the recent lapse of a deadline to appeal through the courts may seem like the end of the road – but rest assured – this is not the end of the road for affected products. Did you know that you can request an administrative review of your MDO and the steps FDA took in reaching its decision on your PMTA submission? There is, in fact, an administrative appeals process written into the very regulations which govern PMTAs, and which your company can engage to both learn about FDA’s processes in reviewing your products and PMTA submission, and to ensure you received a fair and thorough review.

It is prudent for companies to do some homework first, and obtain FDA’s internal records related to their review of the PMTA. This way you can understand what their basis was for even issuing the MDO in the first place – provided FDA even carefully analyzed your submission. Having this data will also ensure that when you do engage in the review with FDA, you come prepared with well-crafted arguments in support of your appeal.

The request for internal review should be a thorough and compelling argument as to why your company disagrees with FDA’s conclusions, and why your PMTA merits a second look. To put together such a compelling case, you should be prepared to parse through FDA’s PMTA standards, particularly its standards for assessing APPH – appropriate for the protection of public health – and to make reasoned arguments for your product(s) based on the materials you obtained from FDA’s review of your application.

Following the internal review, FDA may do one of three things:

• Uphold the decision (the original MDO decision),

• Overturn the original decision (in part, or in full) and issue an Order, or

• Direct a second internal analysis of your PMTA

If you do not receive the outcome you were looking for following Supervisory Review, there are indeed more appeals to be had. The next step would be to appeal to the FDA Commission through a process designated for such second-level appeals, and finally, to an administrative law judge. Once all of these avenues are exhausted, some companies may wish to appeal through the law courts. All of the above are viable, and step-by-step, options for companies who believe FDA should take a second look at their PMTA and the safety of their products. Each has its own process, so companies seeking appeals should be prepared to follow FDA’s processes at each stage to give their appeal the best shot at success.

Want to learn about your options? Contact us using the information provided below.

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