INTERVIEW: FDA leads int'l efforts to harmonise regulatory approaches to generic drugs

Ashraf Amin , Wednesday 25 May 2022

In an exclusive interview with Sarah Ibrahim — associate director for Global Generic Drug Affairs at the US Food and Drug Administration (FDA) and the first Egyptian-American in such a leading position — Ahram Online discussed Ibrahim’s journey from Cairo University to her current position.

Dr. Sarah Ibrahim Associate Director for Global Generic Drug Affairs at FDA
Dr. Sarah Ibrahim Associate Director for Global Generic Drug Affairs at FDA

 

Ibrahim also elaborated on her efforts to harmonise generic drugs’ regulations in order to ensure the provision of high standard and affordable drugs — a matter that saves billions of dollars annually and is crucially important to the US and low- and middle-income patients around the world.

Ahram Online (AO): Would you tell us about your career path from Egypt to your current position at the FDA?

Sarah Ibrahim (SI): I was born and raised in Egypt. I studied at Cairo University’s Faculty of Pharmacy, where I graduated the top of my class and then served as a faculty member for two years, in which I truly enjoyed interacting with my students, who continued to inspire me with their endless motivation.

I then pursued a PhD scholarship at University of Cincinnati’s School of Pharmacy in the US, from which I graduated in record time. After concluding my PhD, I was hesitant between going back home or staying and acquiring experience in the American pharmaceutical industry.

I settled on joining the industry as a formulation development scientist and dedicated my focus at the time to transdermal (application of a drug through the skin) and ophthalmic drug delivery.

It was a very unique field that not a lot of people were specialised in that, one that I chose to pursue due to my passion for learning new subjects. After working in the pharmaceutical industry for numerous years, I then decided to return to academia as an assistant professor at an academic institution in the state of New Jersey.

That is when I received an offer from the FDA related to my research experience in transdermal studies. As you are well aware, the FDA is the federal entity within the health and human services department that researches the effects of drugs and issues regulatory control on their production and distribution. 

I joined the FDA’s Centre for Drug Evaluation and Research seven years ago as a pharmacologist in the Pharmaceutical Quality Department, where I reviewed hundreds of new drug applications awaiting approval for clinical trials. I was then later promoted to my current position.

AO: What are your main responsibilities as associate director for Global Generic Drug Affairs?

SI: First of all, let me tell you about generic drugs, which are copies of the drugs of more well-known brands. Typically, generic drug developers do not repeat the clinical trials and safety and effectiveness studies that were conducted before by the companies whose drugs they are trying to replicate. This allows these generic drug companies to bring affordable products to the market.

Globally, generic drugs play an integral role in helping address rising healthcare costs and promoting access to medication. With that in mind, regulatory requirements and scientific approaches vary drastically from one country to the other for approving generic drugs.

My job is to ensure through rigorous scientific and regulatory processes that Americans get access to safe, effective, and high-quality drugs. Additionally, we lead the global efforts and develop strategies to manage identified risks and harmonise regulatory approaches of generic drugs.

For example, we have a parallel scientific advance programme that we launched with the European Medicine Agency (EMA). Under this programme, a drug manufacturer can submit an abbreviated new medicine or generic drug application to the FDA as well as a marketing authorisation application for a hybrid product based on the definition of the EMA.

Pharmaceutical companies, through this programme, can meet in real time and receive concurrent scientific advice from the EMA and the FDA. That successful collaboration may provide companies and drug developers with a deeper understanding of the basis of regulatory decisions for both agencies. It also avoids any unnecessary replication of studies.

AO: How are generic drugs represented in the US market?

SI: In the US, drug pricing is not regulated. Healthcare spending on prescription drugs in the US is among the highest in the world. That may explain why 90 percent of prescriptions dispensed in the US are generic drugs.

According to the Congressional Budget Office, these drugs have saved consumers an estimate of $8-10 billion annually, and billions more are saved when hospitals use these medicines.

In 2017, the FDA announced a ‘Drug Competition Action Plan’ that further encourages robust and timely market competition for generic drugs and helps bring greater efficiency and transparency in the reviewed process without sacrificing the scientific rigour underlining the production process.

Additionally, the FDA is helping to remove barriers to the development and market entry of generic drugs so that consumers get the medication they need at affordable prices.

To obtain FDA approval for a generic drug, companies need to show that their product is the same as the on-brand drug so that healthcare professionals and consumers can rest assured that an FDA approved generic drug is as safe and effective as its on-brand counterpart.  

AO: What is the impact of generic drugs on developing countries?

SI: Though the price gap between a brand and a generic drug tends to be narrower in developing countries, generic drugs allow wider accessibility to patients due to the lower cost.

This is an important factor, especially with the global drug shortage. In low-middle income countries, drug expenditures account for about 20 to 60 percent of total healthcare spending. It also creates competition in the market that leads to affordable treatments for more patients.

AO: Would you tell us about the FDA’s current efforts regarding new and generic drugs treating COVID-19?

SI: The FDA is committed to providing the timely recommendations, regulatory information, guidance, and technical assistance necessary to support rapid coronavirus disease response efforts.

We are continually working to promote drug innovation and improvement; strengthen quality assurance, safety, and supply of drugs; and enable more efficient use of industry and regulatory resources.

AO: What are possible areas of collaboration with the Egyptian Drug Authority (EDA)?

SI: The FDA continues to explore what regulatory, scientific, as well as technical measures we can take to further harmonise generic drug standards globally.

We have engaged with international organisations and world leading regulatory authorities. We also work with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), which is the global venue for harmonisation of standards for pharmaceutical drugs.

Historically, the ICH focused on developing international standards for new drugs. In 2018, at the FDA’s urging, the ICH adopted a proposal for developing scientific and technical standards for generic drugs and called for a working group on the matter.

The ICH then called for a guideline on standards for demonstrating bioequivalence for immediate release of oral dosage forms of drugs. With variations in the regulatory approaches around the globe, harmonisation can be achieved through the greater understanding of counterpart approaches.

In 2021, the FDA launched an initiative of the generic drug cluster for the leading regulatory agencies to achieve a common understanding of each agency regulatory requirement regarding generic drug development. These regulatory agencies identified a common need and a common goal in the presence of confidentiality and commitment to allow the exchange of information to occur.

Returning back to your question, Egypt is an observer but not a member of the ICH. It is important to revert that question back to the Egyptian authorities to see what they can contribute to the FDA’s regulatory efforts.

AO: How were you able to switch careers from a scientist to a regulatory policymaker? 

SI: Every step you take requires learning. Growing from one position to another necessitates gaining certain skill sets. I do see a lot of scientists who are more comfortable being in the lab and publishing research. That’s a preference; it requires a moment of reflection with oneself to define your strength and capabilities and how far you are comfortable in dealing with new challenges.

It also requires appropriate leadership that is able to see these skills sets in you and set you on a path where you can utilise your potential. I should acknowledge that the FDA has fully invested in me to be effective in the role that I currently represent.

AO: What advice would you give to the young girls in Egypt who would like to pursue a career in science?

SI: When I was a student of pharmacy in Egypt, I thought that I would be truly lucky if I ever got to walk the hallways of the FDA. I couldn’t have dreamed what I have reached now.

I would advise future scientists to dream as far as their heart can muster and they will surely succeed.

Every success story that you hear about is not unattainable by others. You are capable of achieving even more. You can be successful in any country you choose to live in; you just have to utilise the resources you have, continue working hard, have faith in your abilities, and never give up.

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