FDA regs: The Cost of a PMTA

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The new FDA e-cigarette regulations require the manufacturer to make the case that their product ‘presents less risk than other tobacco products’ among other things. In the absence of a predicate tobacco product, the case is made in a Premarket Tobacco Product Application (‘PMTA’).

But for a range of e-liquids, for example, how much does a PMTA cost?

The cost of preparing a PMTA is largely down to how much you are prepared to spend in order to build a case to argue that the candidate product meets the requirements. Naturally, the more you spend making the case the more likely the application will be successful in the first instance. But there are some finite costs which allow us to come up with a useful estimate.

Below are the ‘back-of-the-envelop’ minimum and maximum costs to compile a PMTA. Broadly speaking, the costs fall into 3 main areas:

 

Clinical 

 

£4,000 – £6,000 [1]

 

Non-clinical (toxicology)

 

£3,000 – £5,000 [2]

 

Manufacturing 

 

£3,000 – £5,000 [3]

 

TOTAL

 

£10,000 – £16,000 [4]

 

FDA questions

 

The PMTA application process allows for the FDA to respond to the applicant with questions on the submission. They may query the submitted data or request more information on any aspect – clinical, toxicology or manufacturing.

In light of this, applicants should allow for a contingency fund in order to provide a robust response to the FDA.

 

Timeframe

 

Manufacturers intending to compile a PMTA may need to consider an upgrade of their manufacturing process in order to meet the new product standards – this is likely to be the most time consuming step in the process: 3-6 months. Dossier preparation of the clinical, toxicological and manufacturing sections we expect would require 1 – 2 months.

 

Reusing EU-TPD data

 

A manufacturer that has submitted EU-TPD notifications can reuse the toxicology and manufacturing data to some extent. However, additional analytical laboratory testing is likely to be required in order to meet the stricter requirements of the FDA. Manufacturing and toxicological sections will require amendments to be in line with US terminology. Furthermore, the level of scrutiny by the FDA – at this current time – appears to be greater than that of the EU. This means documents such as the test method (and corresponding method validation) submitted in TPD notifications are likely to fall short of the FDA requirements.

 

How can we help?

 

The PMTA requirements are very similar to medical dossier requirements. Our knowledge and experience in preparing medicine registration dossiers allows us to help applicants build a PMTA dossier for a range of e-liquids or devices.

Please contact us to learn more about how we can help. Read a summary on the FDA requirements here.

Notes:

  1. Estimate based upon supportive literature review (no clinical trial).
  2. Figures are based on reusing tox profiles generated as a result of preparing the EU-TPD notifications.
  3. Estimate does not include analytical laboratory testing costs such as emissions testing. However, EU-TPD emissions data could be reused.
  4. Total cost does not include FDA fees or regulatory consultancy support fees.
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