Pharmaceutical companies extensively use the FDA citizen petition to delay the entry of generic drugs into the United States Medicine market. To counter the Drug Price Competition and Patent Term Restoration Act which makes generic drugs available to the general mankind.
A citizen petition was introduced.
Petitions regarding citizens can be used from regulating policies to issuing laws on provisions of products. FDA Citizen Petitions are important because it is a public process that allows the petitioners a right to knowledge and the people concerned, be it the patients, the stakeholders, or the concerned doctors. It is out in public to jurisdiction. Also, the amends and the solutions everything is kept on record for public view and further reviews.
What is FDA Citizen Petition?
The FDA citizen petition is a process provided by the United States Food and Drug Administration for individuals and community organizations to make requests to the FDA to amend changes in healthcare policies.
Found in the Title 21 of the Code of Federal Regulations (21 CFR Part 10), Citizen petition
There is a stipulated period given to the FDA to reply. Firstly it was 180 days, but then due to amends, it got changed to 150 days. Following this, if FDA fails to respond, it will have to face jurisdiction themselves.
Who can file for Citizen Petition: Citizen Petitions are mostly filed by the drug companies, but the public can do the petitions. Anyone affected by any stringent laws exclusively under the FDA can file a petition and request to take any action against the whole issue or even request necessary changes to the law. The FDA then can do a clear verification and bring injustice to the petitions requested within the given frame of time.
Impact of the citizen petitions
The impact has been eminent since the first petition filed. More companies and individuals are joining the fight for their regulatory actions. Regular amends and response by FDA have been encouraging as well. Famous FDA Advocate and Researcher Scott Lassman and several have researched and written several articles about the laws and actions, making companies and individuals aware of it.
Citizen Petition under Section 505(q)
Section 505(q) is an act amended by the Hatch-Waxman Act. This section states that the FDA cannot afford to delay approving an ANDA to the concern raised in a citizen petition unless it was necessary to protect their health. It is also mandatory that the FDA needs to respond to a petition within 180 days.
In trying times of today, FDA Citizen Petitions are important and very much needed to picture a clear view of all the amends, laws, and jurisdiction concerning public health. The petitions and jurisdictions are highly transparent and are recorded in the administrative view. New amends to the laws and regulatory acts are always important.
tagging: citizen petitions