FDA Matters Mailbag: Hatch-Waxman, Biosimilars, User Fees and More

Over the last month, FDA Matters has covered a wide-range of FDA-related topics: the agency, industry, and Congress, as well as medical innovation, user fee reauthorization legislation, food safety and post-market surveillance. The response has been great: FDA Matters has many new readers and I received a number of interesting questions.

Today’s column touches on biosimilars, Hatch-Waxman, user fees and FDA management. Keep the questions coming!

Is FDA becoming too large for food, drugs and medical devices to be in the same agency?

Last summer, the Commissioner re-organized her office to better manage the growing responsibilities and complexity of the agency’s work. She divided the agency’s work into four parts:

  • food and veterinary medicine
  • medical products
  • global outreach and inspection, and
  • administrative matters overseen by a chief operating officer

The key is that each of these individuals has line authority to manage their part of the agency, rather than being a staff advisor to the Commissioner.

With specific regard to foods, there are proposals to move the Center for Food Safety and Applied Nutrition (CFSAN) out of FDA. I believe the Center is best served by being part of the public health focus of FDA.

How do Europe and the US compare in their approaches to biosimilars?

Both the European Medicines Agency (EMA) and FDA are acting cautiously, but in different ways. Europe has focused on a limited number of reference products, building their knowledge and experience one therapeutic category at a time.

In contrast, FDA has already met with sponsors to discuss 11 reference products, presumably covering a number of therapeutic categories. Given FDA’s broader approach, proceeding case-by-case with strong scientific requirements is the best way for FDA to acquire knowledge and experience.

A different comparison was also posed to me: an eager EMA versus a reluctant FDA.  In less than two years, FDA has produced multiple policy speeches and articles, three guidances, held multiple sponsor meetings and allowed several sponsors to begin work. I assure you: FDA is fully committed to biosimilars!

As an aside, anyone familiar with the lack of FDA guidance on product-related social media can tell you how FDA behaves when it is reluctant to act. It looks quite different.

If the user fee reauthorization legislation has the potential to be a vehicle for any FDA-related provision, might Congress re-open Hatch-Waxman?

I shudder at the possibility, but can’t rule it out. I asked a knowledgeable friend what he would propose if given the chance to amend Hatch-Waxman. His reply: get FDA out of the patent enforcement business, yet assure generics the equivalent of the 180-day exclusivity if they win in court.

Since this would benefit generics, a trade-off for innovators could be longer exclusivity for new molecular entity (NME) compounds that lack intellectual property (IP) protection. It might be the same 10 years they receive in the EU or the 12 years for biologics. Similarly, a stronger incentive than 5 to 7 years is needed to generate interest in 505 (b)(2) drug applications in the absence of IP protection.

I’m not suggesting this, but thought it interesting enough to give his ideas some visibility.

Companies are telling me: it’s hard to justify investing in the US biosimilars market because of the resources it will require. Why is FDA Matters so optimistic?

I hear some of this, too. Certainly, the first generation of biosimilar applicants (and there seem to be plenty of them) are going to pay more–and live with more uncertainty for a longer period of time– than those that start 5 years from now when costs have dropped.

However, those who are successful are going to be rewarded, as I explored more fully in How Biosimilars Will Transform the Marketplace. Put simply:

  • If the first biosimilar approvals from FDA are for solid products with good data and fair pricing, then hospital purchasing groups, pharmaceutical benefit managers and formulary committees are going to move significant market share away from the reference products.
  • In multi-product categories, the market shift may be even greater because there will be therapeutic substitution, not just substitution of the biosimilar for the reference drug.

I look forward to more reader questions!

adapted and republished with permission by FDA Matters, a weekly blog covering FDA policy and regulation

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