Repeal of Regulation Requiring an Approved New Drug Application for Drugs Sterilized by Irradiation
Repeal of Regulation Requiring an Approved New Drug Application for Drugs Sterilized by Irradiation OPEN
2018-10-31 2018-10-09 2018-09-21 2018-10-09
FDA-2017-N-6924-0013 FDA-2017-N-6924-0011 FDA-2017-N-6924-0010 FDA-2017-N-6924-0012
04:00:00 04:00:00 04:00:00 04:00:00
https://api.regulations.gov/v4/comments/FDA-2017-N-6924-0013 https://api.regulations.gov/v4/comments/FDA-2017-N-6924-0011 https://api.regulations.gov/v4/comments/FDA-2017-N-6924-0010 https://api.regulations.gov/v4/comments/FDA-2017-N-6924-0012
Anonymous Anonymous Anonymous Anonymous
Anonymous Anonymous Anonymous Anonymous
As a current quality contributor in the Pharmaceutical industry, I fully support the repeal of regulation 310.502(a)(11) requirements. As noted within the summary and conclusion, necessity for this provision was put into place in 1955 due to the lack of technological understanding / control of nuclear radiation for sterilization of OTC drugs in comparison to the current sterilization and cGMP practices. It is the responsibility of the government and its agencies to facilitate the elimination of outdated and unnecessary regulations bogging down the health care system resulting in, but not limited to, a positive impact on the public,  the market, achieve the cost savings the public desire, and possibly allow for greater ease access to medication needed.  As a member of the healthcare industry I am in full support of the repeal of the requirements in 310.502(a)(11) necessitating  an NDA for irradiated sterilization of drugs.  As highlighted in the summary, this requirement was put in place in the 1950s when radiation technology was still in its early stages.  As the technology has become more refined, research has shown many benefits to using this sterilization process with no adverse effects to the environment or to individual consumers.  It is the responsibility of the government and its agencies to serve people effectively and eliminating outdated regulations is an integral part of achieving that.  The cost savings will be significant and a safer product will reach consumers more consistently.   I concur with the conclusion that technological understanding has advanced to the point where we realize that drugs sterilized through radiation are the same drugs and non-irradiated ones.Repealing this categorization would provide a positive economic impact, reduce paperwork, and speed the process with which this treatment can be used to get drugs to market faster. I support the deregulation of requiring a new drug application for drugs sterilized by irradiation.  As stated in the proposal, the regulations under which this pre-approval was created date back to 1955 when irradiation was not as understood as it is today.  Radiation of active ingredients in medications is very common and there have been extensive research studies supporting this method of sterilization, showing this method to be safe and effective (Abuhanglu  Ozer, 2014).  By removing the regulation requiring an approved new drug application for drugs sterilized by irradiation, medication can be more available to the public at a more cost effective rate.  This benefits the consumer of OTC drugs by increasing drug availability while reducing cost. Abuhanoglu G, Ozer AY. (2014). Radiation sterilization of new drug delivery systems. Interventional Medicine  Applied Science. 2014;6(2):51-60. doi:10.1556/IMAS.6.2014.2.1.