FDA Begins Reorganization

Updated October 9, 2019

How do you know if a pill is safe and effective? For instance, have you ever wondered whether to get over-the-counter meds or something doctor-prescribed instead? How can you make an informed decision?

What's in this Guide?

Disclaimer: Before You Read

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If you ask the pharmacist or a doctor, you’ll only get an opinion. If you visit the manufacturer's website or talk to a pharmacy rep, you’ll get a spiel.

So, how do you find the truth? It’s simple: see if the pill is FDA-approved. 

Government scientists and other experts have done the work for you of trying to discover the truth about a new drug.

You don’t have to rely on opinions and claims to decide because the FDA only approves products after scientifically researching the manufacturer’s claims and gathering data about user experiences. 

The Role of the FDA

The Food and Drug Administration (FDA) protects the public health by reviewing the safety and effectiveness of new products.

They review the safety, security, and efficacy of products such as medications, veterinary drugs, medical devices, and cosmetics.

They also review biological products, radiation-emitting devices, and the country’s food supply. 

The FDA is currently working on a large, multi-phase modernization project to support the development of new drugs for the American public.

New Drugs Regulatory Program Modernization 

Congress has cleared the modernization initiative, and the FDA is now entering the next phase of its plan by reorganizing the Center for Drug Evaluation and Research (CDER).

Their aim is not to change the mission of the CDER but to develop a better infrastructure for future regulatory and scientific purposes.

The purpose of CDER’s new plan is to achieve the following objectives:

  • Enhance the operations of the Office of New Drugs (OND)
  • Strengthen the FDA’s ability to meet the changing needs of the drug review process by adding more reviewing divisions
  • Allow each division to specialize in a specific class or type of drug
  • Augment collaboration between the Office of New Drugs (OND), the Office of Translational Sciences (OTS) and the Office of Pharmaceutical Quality (OPQ) 
  • Restructure the clinical offices and divisions of the OTS and OPQ
  • Promote superior review processes to improve the efficiency, accuracy and quality of drug reviews
  • Improve collaboration between administrators, regulatory project managers, program operators, policymakers, and other key decision-makers

Reorganization Goals

The FDA announced the multiphase modernization of OND, OTS, and OPQ in June 2018.

The primary goal of the reorganization is to create regulatory improvements in departments like Process and Documentation, Administration, and Regulatory Operations.

According to an FDA media report, the new changes will establish the Offices of Program, Administrative, and Regulatory Operations, and it will also introduce an Office of New Drug Policy and an Office of Drug Evaluation Sciences.

The reorganization will not only streamline ONS offices and divisions by grouping them into therapeutically aligned divisions, it will also reduce the workload on employees by adding more offices, divisions, and staff.

The clinical offices that oversee all the review divisions will increase from six offices to eight, and the review divisions, too, will increase from 19 to 27.

In addition, the FDA will also add new divisions in pharmacology and toxicology.

These changes will distribute workload, align with changes in the pharmaceutical industry, increase the level of administrative oversight, and provide better-focused drug reviews.

Benefits of Reorganization

The aim of the reorganization is to improve the efficiency of the organization and provide even higher standards of public health service. 

Once completed, the large project will streamline resources for scientists, doctors, and staff to focus on drugs under the agency's review for unsatisfied medical needs.

Modernizing operations will also make it easier for the FDA to stay current with scientific discoveries and statutory authorities.

Of course, the end goal of the reorganization is to educate the American public about safer, more effective, and higher-quality drugs on the market.

The FDA is keeping up with a brave new world of drug development. This initiative to modernize the agency will help it align with rapid changes in the industry.

On her FDA blog, Janet Woodcock, M.D., Director of the FDA’s Center for Drug Evaluation and Research explains why the drug industry is changing so fast: “Current factors impacting drug development include the genomic revolution, the rise of targeted therapy, the availability of digital health data, the focus on patient involvement, complex drug-device combinations, globalization of drug development and harmonization of international standards.”

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