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Compliance In Focus
Posted by Emily A. Matejka on Fri, May 31, 2019

Major Changes for the FDA

On April 11, 2019 a memo was released from the Office of Management and Budget (OMB) stating that United States agencies, which include the Food and Drug Administration, rules and guidances must go to the OMB’s Office of Information and Regulatory Affairs for review beginning on May 11, 2019.FDA-Commissioner
The OMB will be reviewing the agencies regulations and guidances to determine whether they are classified as “minor” or “major”. Previously, each agency was responsible for determining on its own whether the proposed new rule should be classified as major based on reviewing the CRA criteria, which is listed below.

The Director of OMB requested that all agencies follow the outlined process of submitting the regulations and documents with sufficient and adequate information to prevent delays in making the minor or major determination.

According to the 1996 Congressional Review Act, an agency document is considered to be major under the following circumstances: 

  • It impacts the United States economy by $100 million, or more;
  • Increases costs for consumers, industries, or government agencies; Or
  • Affects the ability of United States companies to compete with foreign ones

If the OIRA determines the agency submitted document to be major, the document must then be reviewed and approved by Congress. The Congressional Review Act (CRA) is a federal law used by Congress and the president as a check on the rule-making activities of federal agencies. This allows Congress to overturn new federal agency rules and prohibit the issuing agency from creating a similar rule in the future. This law was put into place in 1996 by President Bill Clinton, and as of May 2018 there have been 17 rules repealed under the CRA – 1 by President George W. Bush in 2001, and 16 by President Donald Trump from 2017-2018.

In addition to adhering to the new document review plan, the FDA has also been responding to President Trump’s 2017 executive order to withdraw two regulations for every new one issued. This has now become known as the “2-for-1” order. As of October 2017, the FDA had withdrawn at least 10 rules in response.

What are some concerns or benefits that may come with repealing different FDA regulations?

What could this mean for researchers?

Reference: Shawn M. Schmitt ‘Major’ Pain for FDA: Under OMB Directive, Congress Will Vote On So-Called ‘Major’ Rules, Guidance Docs MedTech Insight, 06 May 2019

GCP Auditing


Topics: FDA, Office of Management and Budget


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