NCHR Testimony at FDA on the Hatch-Waxman Amendments

Good afternoon.  I’m Jack Mitchell, Director of Government Relations at the National Center for Health Research.  NCHR performs original health research to inform public policy and legislation.  We also advocate for patients and consumers.  In addition, we help manage an informal coalition of approximately two dozen non-profit organizations which focus on public health issues.  NCHR accepts no funding from pharmaceutical or medical device companies, so I have no conflicts of interest to report.

We agree with Commissioner’s Gottlieb’s recent blog posting and subsequent comments that brand name companies are sometimes gaming FDA’s regulatory rules in ways that unduly delay generic drug approvals beyond the time frame that the law intended.  Generic drug companies usually need 1,500 to 3,000 doses of the originator drug to use for testing.  Some companies are using regulatory strategies to deliberately block access to testing samples.

For example, branded companies might use restrictions they place in the commercial contracts or their agreements with distributors to make it more difficult for intermediaries in the drug supply chain to sell the drugs to generic drug developers.  Or, branded products are sometimes subject to limited distribution, either through REMS or the company’s voluntarily adopted limitations.  These longstanding hurdles need to be corrected or amended.

We also believe that it should be possible for generic sponsors to buy the branded products for testing at affordable prices.  This is especially important since the most expensive branded drugs are making healthcare increasingly unaffordable for many patients and consumers.   And, one of Dr. Gottlieb’s stated strategic goals is to reduce high drug prices.

The Commissioner also pointed out that besides limiting access to testing samples, some branded companies may be using the statutory default requirement to have a single shared REMS across both the branded and generic versions of a drug as a way to block generic entry.  These single shared systems can be used to delay the entry of safe and effective generic drugs onto the market.  This delaying mechanism also must be addressed.

Finally, we want to express our concerns about various mechanisms that have been used to extend patent protections on drugs, including the so-called “pay for delay” tactics long utilized by the major brand manufacturers.  It is well known that some of these mechanisms have ended up increasing the costs of treatments and have provided relatively little benefit regarding access to safe, effective, and affordable treatments available to children or patients with rare diseases.

In summary, the legislation popularly known as the Hatch Waxman Act, named after its two primary Congressional sponsors, has had a significant impact on increasing drug innovation and access to cheaper but effective generic drugs.  For all the success of these legislative measures in expanding care, there needs to be a bit of a course correction.

We have no specific recommendations today, but NCHR will address those in the comments to the FDA docket.   However, we concur with several of the suggestions made this morning by Professor Michael Carrier of Rutgers University Law School in his presentation.  Those recommendations include FDA consideration of requiring drug sample deposits in advance of approval to assure their timely access for future testing to generic manufacturers.   We also agree with suggestions to address REMs-related and citizen petition abuses which cause long delays in getting generics to the marketplace.   These suspect practices are longstanding and a violation of both the spirit and intent of Hatch-Waxman.

Lastly, we hope FDA will follow the Commissioner’s recommended course of action to further improve this system for the future benefit of patients and industry alike.  Thank you.