Regulatory Focus™ > News Articles > Senate Bill Seeks Faster, More Predictable Approvals for Time and Extent Applications

Senate Bill Seeks Faster, More Predictable Approvals for Time and Extent Applications

Posted 26 August 2014 | By Alexander Gaffney, RAC

Senate Bill Seeks Faster, More Predictable Approvals for Time and Extent Applications

Senate legislators have released a new iteration of the Sunscreen Innovation Act, a bill which seeks to accelerate the approval of long-delayed new sunscreen ingredients in the US, which would go beyond sunscreen ingredients to overhaul part of the process used to approve over-the-counter (OTC) drugs.

Background

As explained in our article on the House version of the Sunscreen Innovation Act, the bill has long been focused on the Time and Extent (TEA) application process. The regulatory pathway allows companies to submit a marketing application based not on clinical data, but instead based on a product's use and the time it has been marketed in another country or region.

Sponsors of TEAs must undergo a five-part process, any part of which can experience lengthy delays:

  1. Sponsor must generate a TEA application, including information about the drug, the time and extent of its marketing and its use.
  2. FDA must then determine if the drug is eligible under the monograph system. In essence: Would this drug be able to be used without the supervision of a healthcare professional by most people?
  3. The TEA submission is then opened to public comment, including comment from rival manufacturers and public interest groups.
  4. FDA determines whether the ingredient is generally regarded as safe and effective (GRASE), and thus eligible under the monograph system.
  5. FDA then proposes and later finalizes a regulation (rule) on adding the drug ingredient to the sunscreen monograph. In some cases, it also publishes an advanced notice of public rulemaking, which is a notice that it plans to issue a draft regulation in the future.

While the TEA process is meant to be speedy in concept, in practice it has proven to be anything but. Since FDA lacks the data it often relies upon for approvals, it has delayed some ingredients for nearly a decade, seeking more and better data in support of TEA applications. In addition, because products are approved in different ways across regions—sunscreen ingredients are actually cosmetics in the EU—it can often be difficult to rely upon data from outside the US.

Senate Bill: TEA Time for FDA

But while the House version of the bill has focused its energies on creating a process by which sunscreen ingredients could make it to market faster, the Senate's focuses on the entire TEA process.

The new bill is called the Sunscreen Innovation & Other Time and Extent Applications, and it builds upon the existing legislation.

The bill is substantially similar (but not identical) to the Sunscreen Innovation Act up until Section 3 of the discussion draft, which focuses on "non-sunscreen" TEAs. The section allows FDA to "enter into an agreement with the sponsor [of an existing TEA application] to provide for the timely review of safety and effectiveness data for the purposes of making a GRASE [generally regarded as safe and effective] determination."

If FDA and a sponsor can't come to an agreement, FDA will be required to provide the sponsor with a written statement as to why it is not feasible to do so, the bill states. FDA will also be required to notify Congress.

New TEA applications will be subject to enhancements as well. The bill calls for "timely and efficient completion of evaluations" that reflect FDA's "public health priorities," FDA resources, the complexity of the submissions, and other requirements. The bill does not yet prescribe any concrete review timelines, however.

The Senate bill, if passed, would need to be approved again by the House of Representatives before it could go on to the president for final approval.

 

Senate Statement on the Discussion Draft


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