FDA Chief Counsel Sheldon
Bradshaw spoke for the first
time before the generic industry
at the Generic Pharmaceutical
Association's (GPhA) policy
conference in September, and
his remarks were encouraging.
Specifically, Bradshaw noted
that citizen petitions are a growing
concern not only for the
generic industry, but for the agency as well.
Every US citizen has a constitutionally protected
right to petition the federal government. Some brand
name pharmaceutical companies, their lawyers, or
others frequently file citizen petitions regarding pending
Abbreviated New Drug Applications (ANDAs)
with the FDA, however, on the eve of approval. Upon
receipt, the FDA typically delays ANDA approval
until the issue underlying the citizen petition is
resolved. Citizen petition filings regarding ANDAs
have increased in recent years, sometimes substantially
delaying generic drug approval times and consumers'
access to affordable medicines, while extending
branded companies' product monopolies.
In his speech, Bradshaw said that he wants to ensure
that generic approvals are not significantly delayed by
citizen petitions. "The citizen petition process is in
some cases being abused. Sometimes, stakeholders try
to use this mechanism to unnecessarily delay approval
of a competitor's products," said Bradshaw. "I've
already seen several examples of citizen petitions
designed not to raise timely concerns in respect to
legality or timeliness of the drug application, but rather
to delay approvals by compelling the agency to consider
arguments raised in the petition, regardless of
whether the arguments in the petition could have been
argued months and months before. I've found that to
be particularly troublesome."
In most cases, the FDA does not find the reasons
outlined in the petitions to modify ANDA approval
requirements to have any merit. "We would welcome
ideas as to how we could improve the process, such as
putting responses and approvals on 2 separate tracks,"
Bradshaw said. "Decoupling is certainly out there and
seems an obvious solution," he continued, "but I want
to hear other views."
GPhA welcomes that opportunity to present the
views of the trade association and its members on this
critical issue. Now that the FDA has recognized citizen
petitions as an important issue, we are hopeful that it
will continue to generate more attention at the agency.
Consumer access to affordable medicine should not be
delayed by citizen petitions that are questionable.
Kathleen Jaeger, RPh
President and CEO
Generic Pharmaceutical Association