In a year marked by rapid technological shifts and mounting political pressures to solve pharma-related policy issues, U.S. regulators have had their work cut out for them. But at the start of the year, the U.S. Food and Drug Administration’s commissioner, Scott Gottlieb, laid out a policy roadmap for the year that promised to tackle some of the country’s thorniest health troubles.

By and large, the agency has delivered on its promises, crafting a range of new guidance documents and regulations that address critical pharma policy areas such as opioid addiction and prescription drug costs.

But the important question is: What does all this mean for pharma manufacturers?

It’s no secret that staying on top of regulations is a daunting but necessary endeavor for the pharma industry. To help navigate the shifting landscape of pharma regulations, we’ve put together an easy-to-follow guide of the most noteworthy changes in 2018.

The new policies target everything from drug discovery and approvals to facility inspections. Other changes, such as those related to opioids, represent a cultural watershed for the industry, that could be felt for decades.

Here are the biggest hits from 2018 and what you need to know to maintain your company’s regulatory intelligence.

Generics: Pharma’s Cover Songs

Prescription drug prices continue to be one of the most vexing issues facing the industry. President Donald Trump has been notably outspoken on the issue, using hostile language toward “Big Pharma” and promising to drive costs down.

Meanwhile, the FDA strategy for addressing the issue has been to promote generics, with the goal of getting more of them on the market. In addition to streamlining the process of getting generics approved, the FDA has been working on ways to prevent manufacturers of brand-name drugs from “gaming” the system and blocking generics from entering the market.

GDUFA II
Back in 2012, the Generic Drug User Free Amendments (GDUFA) were passed as part of the Food and Drug Administration Reauthorization Act. For the first five years, the FDA put the pieces in place to achieve the primary goal of GDUFA: bringing greater predictability and a faster timeline for getting generics reviewed and approved.

Late last year, the plan was reauthorized (and is now known as GDUFA II), and the results of the previous five years are now being felt in the industry. From the perspective of Srinivasa Rao, vice president and head of Regulatory Affairs-North America Generics for Dr. Reddy’s Laboratories, a multinational pharma company that specializes in generics, the impact in 2018 was enormous.

“I’ve been doing this for 20 years, and I’ve seen a huge change with GDUFA II,” Rao says. “Back in the 90s, it might take an application for a new generic drug 20 to 25 months to get approved. Now, the timeline for a high-quality application could be as fast as eight to 10 months.”

To expedite applications, the agency increased its review staff, which meant it had to ratchet up the cost of application fees. Prior to 2012, there was no fee for applying for a generic drug approval. In 2018, however, the cost was as high as $172,000 for an Abbreviated New Drug Application (ANDA) and in 2019, will increase to $179,000. But Rao says that for Dr. Reddy’s, which files an average of 25 ANDAs per year, the extra fees are worth the speedier approval times.

“The FDA has given us more clarity through guidances and controlled correspondences,” he says. “In addition, there is another new approach called a Pre-Submission of Facility Information Related to Prioritized Generic Drug Applications, where you have the opportunity to get an expedited review and ANDA approved in eight months if you send the required data ahead of time.”

Created in 2017, the Pre-Submission option allows companies to submit accurate facility information in advance of their ANDA to help expedite review.

Overall, Rao says the changes have been a major win for consumers, and despite the increasing competition on the generics scene, GDUFA could incentivize more companies to enter the generics market.



Global Harmonization
At total of 16 countries have now signed on as members to the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), along with 28 observer countries. The goal of ICH is to help create global standards for medicines, which could become a key driver in bringing more generics to the global market.

This past November, Gottlieb submitted a proposal to the ICH recommending the development of internationally harmonized guidelines on scientific and technical standards for generic drugs.

“The lack of harmonization across such basic components of generic drug development reduces the opportunities for generic drug developers to use their data and information across multiple applications in different jurisdictions. The result is increased cost and complexity to generic drug development,” Gottlieb said in a statement. “As a consequence, generic drug developers with limited resources sometimes must choose only a limited number of countries where they’ll apply for marketing approval.”

According to the FDA, Gottlieb’s draft Reflection Paper on the issue was endorsed by the ICH Assembly, and Gottlieb said the FDA will continue pushing for policies to create global, harmonized standards for generic drugs.