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Obtaining Generic Drug Approval in the United States

Submitting an abbreviated new drug application to the Food and Drug Administration

Generic Drugs are Critical for Cost Savings

The US Food and Drug Administration (FDA) approved over 700 generic drugs in 2015 alone, which was the highest to date, based on a report published by the FDA’s Office of Generic Drugs (OGD). The report also stated that the Agency approved 99 generic drugs in December 2015, which reflected FDA’s accomplishment report to Congress from March 2016.

These approvals are a vital way in which FDA is now capable of keeping the costs of medications in check, especially at a time when generic drugs account for approximately 88% of prescriptions doled out in the US. This important measure has saved the health system in the country by a whopping sum of $1.68 trillion from 2005-2014.

When can Generics Launch

Generic drugs are copies of a brand-name medication developed by another firm. Generally, these drugs sell at relatively lower prices, and promote competition in the pharmaceutical industry.

These drugs are the same in strength, safety, quality, dosing, the way they are taken, the way they work, and the way they ought to be used as that of the parent drug.

A generic drug can be marketed only after the patent of the brand-name product expires. For more, see When do Drug Patents Expire?

Steps to Get an Approval for Generic Drugs

The approval of generic drugs takes time. The FDA has to peruse the complex information required to exhibit that a particular generic drug can be safely and effectively substituted for the brand-name drug it is based on.

Manufacturers in the US have to file an Abbreviated New Drug Application (ANDA) with the FDA’s Center for Drug Evaluation and Research (CDER) for approval.

Generally, an approval application for a generic drug that is submitted to the FDA must highlight the following facts:

  • The drug is pharmaceutically equivalent to the original branded drug
  • The “active ingredient” should be the same as that present in the branded drug
  • The appropriate quantity of the “active ingredient” has to get in the right place within the body and deliver the same results as the branded drug
  • The manufacturer should be capable of producing the drug on a consistent basis and in the right manner
  • The inactive ingredients should be safe
  • The manufacturer has to use an appropriate container where the medication will be shipped and sold
  • The label of the generic drug should be the same as the brand-name drug

What Kind of Data Should Generic Drug Manufacturers Submit to FDA?

Generic companies have to submit different types of data to the FDA for examination and evaluation. One of the most important data that has to be submitted includes the process of manufacturing the drug. This information has to shed light on the active ingredient that reverses the disease and also of the inactive ingredients. The data will enable the FDA to know whether the manufacturer is reliable and can make a high-quality product.

The manufacturer also has to prove that the drug will have the same effect on patients as its brand-name medication. Very often, the FDA asks the company to conduct trials on real human beings who are administered both the generic and branded products. The information collected from these trials is then compared to confirm that the generic drug is effective, safe, and can be used instead of the brand product.

Other important information which the company has to show is that the drug will not decay or mellow with time, that they can manufacture the same medication every time, and most importantly, the labeling is the same as the brand product.

ANDA submissions can be made through the Electronic Common Technical Document (eCTD) format. Click here to access a wide variety of resources and support with respect to eCTD submissions.

In case of general information and questions regarding submission of datasets to CDER, manufacturers can email their concerns at any of the following addresses:

  • esub@fda.hhs.gov
  • esubprep@cber.fda.gov
  • edata@fda.hhs.gov

The CDER has developed a guide titled Providing Regulatory Submissions in Electronic Format — ANDAs to help applicants make regulatory submissions in electronic format.

This guidance has to be used along with the following guides:

The Role of FDA Once the Information is Submitted

Researchers, scientists and health care professionals with a broad range of expertise co-operate to ensure that the generic drug so produced is of high-quality, effective, safe and can replace the brand name product. The information submitted by the company and the data gathered by investigators while checking out the manufacturing facilities and related testing are thoroughly examined.

Once the FDA approves the generic drug, manufacturers are supposed to report the unfavorable health effects and problems to the federal agency if any. Furthermore, the FDA makes it a point to routinely oversee manufacturing plants and monitor the quality of the drug. They can also suggest any proposed alterations to the drug even after its approval.

How Long Does it Take for a Generic Drug to be Approved?

This depends on how complex the drug is and how well the application has been filled. Some generic versions of medications, which according to the CDER have the potential to provide considerable improvements in the field of medical care, have taken less than six months for approval. Surprisingly, in most cases, the medical and scientific team of the FDA has taken years to give a green signal.

It should also be noted that many generic drugs have lost approval since the company could not meet the stringent standards for approval as laid down by the Agency.

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