President’s Budget Has a Hidden Change to Hatch-Waxman — Watch Out.

There is a proposed change to 180-day exclusivity which is awarded to the first -to-file (FTF) applicant with a paragraph IV certification.  The proposal would trigger the 180-day exclusivity period if a subsequent applicant obtains tentative approval prior to the FTF applicant gaining final approval.  While this on its face may in some instances appear to permit a generic applicant to enter the market faster, it could have unintended consequences that may have not been yet investigated.

There may be certain reasons why an FTF applicant can’t yet get to final approval other than them seeking to delay entry into the market.  As we have seen in some prior instances, small tweaks to the Hatch-Waxman Act can have significant unintended consequences that are not initially obvious.  But months or years later we find that the tweak has actually caused a bigger problem than the tweak fixed.

So be careful about support and accepting change without completely understanding how the change can impact the industry down the line.  As Commissioner Gottlieb has said “it time to end the shenanigans” of the brand industry, just remember when a short sentence requiring an ANDA applicant cannot change the original reference listed drug in its application, was inserted into a prior piece of legislation.  It took about 3 years until the impact of that short sentence became apparent.

Keep an eye on this and make certain it does not become another single RLD-like issue.