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Can the US Government Overrule the FDA's Approval for a Drug? by Complianz world
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Can the US Government Overrule the FDA's Approval for a Drug? |
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Health,Government,Advice
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Recently the US government has overruled the FDA’s approval for a drug. The drug in question is PLAN B, the first ever emergency contraceptive drug which came into existence in the year 1999. This drug soon came under the scanner and the reasons were many. First and foremost, there were the social and moral reasons and most people were unhappy because of the availability of the drug. Then there was a tussle over the drug being available over the counter than being a prescription drug, triggering a 14 year long court battle which also saw many citizen petitions. In the year 2001, citizen petitions were submitted to the FDA by many health organizations and family planning organizations to allow this emergency pregnancy drug to be sold as OTC. FDA however rejected the plea, and by 2006 it was instead stated that this drug can only be sold as OTC to women who are 18 years and above and that these customers need to provide their age proof. It still remained as a prescription drug to women below the age of 18. This decision of FDA to keep PLAN B as a prescription drug for women under the age of 18 was not acceptable to many. Plaintiffs or complainant thus put forward many complaints against the FDA’s rule in the court of law. •It was stated that FDA’s ruling of PLAN B not being available to women under the age of 18 was unlawful because Supplemental New Drug Application (SNDA) could not demonstrate the reasons for PLAN B to be safe for OTC for women above 18 years of age. •FDA was even criticized for defying the ruling of FDCA (Federal Food Drug and Cosmetic Act) as they have allowed this drug to be sold both as OTC and as a prescription drug. •FDA was considered to have violated APA (Administrative Procedure Act) and FDCA as they failed to carry out rule making. •They also said that FDA did not have the authorization to impose such administrative decisions. In April 2013 a Brooklyn based federal judge ordered FDA to make PLAN B available to any age without a prescription. This knocked over the decision of Kathleen Sebelius (Health and Human Services Secretary) who in 2011 stated that this drug must only be available to girls of 18 years and above. Judge Korman said "The decisions of the Secretary with respect to Plan B One-Step and that of the FDA with respect to the Citizen Petition, which it had no choice but to deny, were arbitrary, capricious, and unreasonable." Judge Korman also added that it was the constitutional right of the people “to obtain and use contraceptives.” He also stated – “FDA’s authority over non-prescription drugs does not extend to restricting the point-of-sale distribution of drugs that have been found to be safe ‘when used in the manner intended.’” Judge Korman’s decision shows that the US government does have a say in the decisions of the FDA and can even over rule them if and when required. Complianz World, a leading GRC training provider, brings a range of topics related to compliance - Pharmaceuticals , Biotechnology , Medical Devices , FDA Compliance , Clinical Research , Laboratory Compliance , Healthcare Compliance , Banking and Financial Services (BFSI) , Human Resources (HR) , OSHA , Trade and Logistics , and GRC Regulations delivered through webinars by industry experts.
Related Articles -
FDA, PLAN B, Supplemental New Drug Application (SNDA), APA (Administrative Procedure Act), Non-Prescription Drugs,
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