A Wake-Up Call for Generics-Makers: FDA Accepting Only Electronic Submission in 2017

Generic drugs have saved billions of dollars for health care consumers, providers and payers. And the market shows no signs of slowing down. According to the US Food and Drug Administration (FDA), nearly 8 in 10 prescriptions filled in the United States are for generic drugs, totaling more than $70 billion in 2014.This demand has been intensified by the Affordable Care Act and other initiatives aimed at lowering national healthcare costs by compelling a move toward less expensive generics and biosimilars.

Soon, however, new mandates by the FDA will have a significant impact on generic drug manufacturers, which are scattered over the world but are relatively concentrated in the AsiaPacific (APAC) region, Africa, and South America. For many generic drug companies in those regions, these new FDA rules will for the first time subject them to the same level of scrutiny, industry standards, and best practices as pharmaceutical companies elsewhere in the world.

The Food and Drug Administration Safety and Innovation Act (FDASIA) dictates that generics and biosimilars companies must now pay user fees to the FDA, and by May 5, 2017 all submissions to the FDA must be made electronically. To comply with these rulings, companies must use Electronic Common Technical Documents (eCTD) to transfer regulatory information to the FDA. This interface is supported and enabled by enterprise document management systems (eDMS). Soon companies will not be able to communicate with the FDA without eDMS systems, and will not be able to make regulatory submissions to the FDA without eCTD publishing software.

These changes will provide some advantages—and challenges—to all drug developers and manufacturers, including to those in the generics industry.

Electronic filing advantage

The FDA’s police are aimed at creating a more efficient global pharmaceutical industry and safer products for consumers. They will streamline the submission and approval process for new drugs. The filings will sharply reduce the time taken for reviewing new drug application (NDAs) or investigative new drugs (IND) applications, which previously had taken up to three years. Electronic data capture and filing tools, properly used, can also significantly reduce data and reporting errors which can clog official filings with the FDA and other regulators.

Electronic filing challenges

The change to electronic filing will require a different set of habits to make eCTD’s flow faster. Rusty technical ability, using Microsoft Word incorrectly, and continuing to view paper documents as official records for the FDA would all create issues from electronic filings. In addition, user fees will enable FDA inspectors to visit foreign drug manufacturing facilities every two years using risk-based methodologies, instead of approximately every seven years.

In the long run, improved compliance will shorten manufacturing cycles, accelerate processes, and improve productivity. Implementing integrated systems, unified data, end-to-end information flow, and standard ways of identifying records across all systems and departments will make pharmaceutical companies more capable, responsive, and proactive. Companies like Synergy Bioscience can help with setting up electronic data and filing systems, and ensure that you can be ready for the switch to eCTDs in May.

FDASIA is a wake-up call for companies in the generic drug industry because the US makes up more than 80 percent of the world market for generics. Generic drug manufacturers, especially in the APAC region,soon will need to comply with more stringent FDA mandates by deploying new electronic document management, quality management, and submission management systems.

Some industry analysts in the APAC region predict that regulators may be forced to make exceptions to the rules because the US wants lower-cost healthcare and so many inexpensive generics come from APAC. Some executives think their companies won’t need to invest in new information systems or enforce best practices. They all are mistaken. The FDA has drawn a line in the sand: If companies want a piece of the lucrative US generic drug market, they can only get it through compliance that will pass the tests of FDA auditors and inspectors.

Investing in a Stronger Industry

Global drug companies that want to preserve US market opportunities must comply with new FDA requirements. Significant investments may be required to achieve compliance. The competitive advantages of best-practice systems and processes have been discussed for many years, but this industry conversation is no longer focused purely on improving return on investment by unifying information. Next year, companies simply won’t be able to submit required forms to the FDA without eDMS systems.

Generics producers that can’t comply by May 2017 risk having to go out of business—especially as the generics market becomes increasingly competitive and consolidates.

Companies that postpone this initiative until the regulations go into effect may find it much more difficult and expensive to achieve compliance. As the deadline approaches, technology vendors with available time and bandwidth may be in short supply as they help other companies install and validate complex information systems. Synergy Bioscience will compile your drug application file in a compliant manner according to the regulatory requirements, select, validate, and implement the proper software that will help you have a comprehensive overview of your submission statuses across a number of products within multiple different geographic markets. Learn more about how we do this on our website.

How well-prepared are you for the new FDA rules? What filing or other systems present your biggest challenge? How much do you think these rules will change the generics market? Let us hear your thoughts.