The FDA has finalized a guidance about citizen petitions against the approval of drugs, which delays the application process, and what they look for in petition submissions as well as why submissions might be denied. This comes after the abundant number of false claims, that lack scientific evidence, against the applicants.
When citizens petition against drugs or medical devices, the FDA freezes the application to protect the public’s health, which causes a delay in the approval of these products. Although citizens have the right to petition, they might delay the application process without any substantial evidence to prove their claims. Since 2008, out of all the petitions sent to the FDA, only 10 of the 192 were granted, while the rest were either denied or partially granted.
Signs of Trouble
Some citizens may want to petition for unethical reasons such as wanting to delay the application for their own financial benefit because they were bribed to do so, ext. Here are some signs that the FDA looks for to see if the petition has false claims:
- An unreasonable length of time between when the citizen learned of the troublesome information of the applicant and when they filed the petition
- Submission of multiple petitions
- Submission without any data or evidence to prove claims
- History of the citizen
For more detailed information, see the full guidance here.
When filing a petition, the citizens would have to fill out a 505(q) certification where they list information such as what problems the product may have, and when and where they learned about these problems. The FDA will deny the petition if the certification does not provide the date (month, day, and year) of when the problem became known to the citizen. Without this 505(q) certification, the petition will not be reviewed. The FDA will notify the citizen filing the application, and they would have to create a new petition and include all the information required by the FDA in order for their petition to be reviewed.
The FDA will not review the application if it does not contain the following verification:
This statement is to ensure that the citizen filing the petition understands the importance of their actions, and that if they give false information or do something unethical, they would not only delay the application process for the drugs to be approved, which could lead to financial and economic loss as well as potential harm to patients relying on these drugs, but they would also be in trouble with the law.
RegDesk Platform intends to provide medical device manufacturers with all necessary information on regulatory issues in an accurate and timely manner. Regulatory requirements incur substantial changes in the market, and to be aware of new amendments and improvements while maintaining compliance with all applicable regulations is extremely pertinent.