FDA Guidance Seeks to Speed Up Approval of Generic Drugs

The U.S. Food and Drug Administration (FDA) has released a series of recommendations for drug manufacturers to follow when submitting applications for new and generic drugs, as part of an effort to fast-track the approval process that allows high quality and affordable medications to be offered on the market.

The agency issued the report this month, Good ANDA Submission Practices Guidance for Industry , outlining the types of deficiencies in the abbreviated new drug applications (ANDAs) that typically delay the approval process, and may delay otherwise beneficial generic drugs from reaching consumers. However, critics say these efforts to speed up generic drug approvals may be causing a health risk for the public, allowing medications to be sold with a less rigorous approval processes.

With increasing numbers of new and generic drug applications being submitted to the FDA each year, there have been significant changes in legislation and regulatory initiatives, which have substantially changed the drug approval process at the agency, resulting in large increases in the number of drugs approved.

Under the FDA’s Modernization Act, the agency requires generic drugs go through an abbreviated new drug application (ANDA) in which data is submitted to FDA for the review and potential approval. The approval program is named “abbreviated” because the drugs are generally not required to include animal and human data to establish safety and effectiveness. Rather, generic drug applications must only demonstrate that their product performs in the same manner as the innovator drug.

However, the agency claims many low-cost, safe, effective, and high-quality generic drugs must later go through multiple rounds of the review processes, which officials say defeats the purpose of the abbreviated process.

In the new guidance, the agency notes generic drugs have to often go through those additional rounds of review due to missing patents and exclusivities, labeling, product quality, or the lack of evidence provided to establish similarity between a generic drug and reference drug.

“Multiple review cycles are highly inefficient, require significant resources from applicants and FDA, and delay timely patient access to more affordable generic drugs,” officials said in the guidance.

As part of an effort to improve the predictability and transparency of ANDA assessments and to minimize the number of review cycles necessary for approval, the FDA is instructing drug makers to include an active pharmaceutical ingredient’s list with specific details related to manufacturing process and controls for impurities, along with ensuring the labeling matches the associated brand-name drug.

While the guidance is not officially binding, the FDA stated the outlined recommendations represent the agency’s current thinking and is intended only to bring awareness to new and generic drug manufacturers submitting ANDA application submissions.

Less Rigorous Approval Processes Means More Risky Drugs

Many say the more rigorous process for review is necessary for public safety however, pointing to a number of drug risks that were uncovered only after medications were allowed on the market.

In September 2017, a study published in The BMJ found one-third of all new drugs approved by the FDA since 1997 went through an expedited process, and those drugs were almost guaranteed to have an average of at least one serious label warning update per year.

In June 2015, The BMJ also published an analysis that warned about numerous discrepancies in data submitted to the FDA by medical device manufacturers seeking premarket approval for heart devices.

Those discrepancies often included the number of participants varying in the actual study from the number reported to the FDA, substantially different results from similar FDA studies, and many of which were never peer reviewed.

Since drug makers and medical device makers often aggressively market new products immediately after the FDA approves the drug, espousing the benefits of their new treatment options, large numbers of unsuspecting patients end up being unwilling test subjects, without any disclosure that the product they are using was not fully vetted to ensure it is safe and effective. These same problems are often transferred to generic drugs, which must be functionally equivalent to the original drugs they are based off.