Generic Drugs

These days, more and more people are choosing to treat their health issues with generic drugs. For example, they make up 90% of prescriptions filled in the US.

This demand for safe copies of well-known medicines, causes a ripple effect that works to the benefit of patients everywhere. It helps to create competition in the marketplace which, in turn, helps to make treatment more affordable which, in turn, makes it more accessible to more people.

In the United States, the FDA's Office of Generic Drugs (OGD) is in charge of ensuring high-quality, affordable generic drugs are available to the American public.

One of their priorities is encouraging more competition through their Drug Competition Action Plan (DCAP) which aims to remove barriers to the development of generic medicines and their market entry. The plan aims to encourage robust market competition and make the generic drug review process more efficient and transparent while ensuring scientific integrity and rigour.

So far, the agency has focused on three key areas, implementing several initiatives to:

• Improve the efficiency of drug development, review, and approval with the aim of facilitating more approvals. Clear regulatory expectations improve the overall quality of submitted ANDA’s from all applicants and supports prospective generic drug producers.

• Maximise scientific and regulatory clarity with respect to complex generic drugs, ensuring that the regulatory requirements are streamlined, predictable, and science-based, to help reduce time, uncertainty, and cost of drug development.

• Reduce so-called ‘gaming’ in ways that allow brand name drug companies to delay generic competition. These delays can hinder development and approval processes, making them more costly for generic manufacturers – a cost that’s passed down to patients.

Generic medications are just as safe and effective as their brand-name counterparts. However, many people have questions about whether they are really as good as the name brand medications and, if so, why are they cheaper?

The FDA works to address this issue by following rigorous review processes, stringently managing the regulatory process, scientific research and producing drug development data and reports. They then offer a wide range of education materials including videos, graphics, fact sheets etc. to educate the general public – all of which is a welcome approach to more and cheaper healthcare for all of us.