Another potential area of opportunity for generic companies is the "Competitive Generic Therapies" as outlined in Section 506H of the FD&C Act, as amended by FDARA ([section] 803).
Generic firms should take note that FDARA [section] 804 which amended the FD&C Act to add Section 5061 requires NDA and ANDA holders to report in writing to FDA "180 days prior to withdrawing [an] approved drug from sale, or if 180 days is not practicable as soon as practicable but not later than the date of withdrawal." (3) In addition, sponsors must notify FDA in writing "within 180 calendar days of the date of approval of the drug if the drug will not be available for sale within 180 calendar days of such date of approval." (3)
"FDARA builds upon the goals outlined in previous user fee agreements and in the 21st Century Cures Act and will help us continue the essential work we are doing in many of our priority areas," directors of the FDA's drug, device, and biologics centers wrote in an Aug.
The FDA Reauthorization Act of 2017 (FDARA) passed by Congress and signed into law in August.
FDARA resolves some of the concerns discussed in the previous section, but it magnifies others.
Nonetheless, the FDARA will lead to at least six significant problems.
The second problem occurs because FDARA not only contains a drug company user fee increase, but will also lead to at least some mandatory postmarket drug testing.
Passage of FDARA by the Senate had been hailed by the Association for Accessible Medicines (AAM).
In a letter to House leaders, Davis said, "FDARA takes important steps to bring more generic and biosimilar medicines to market over the next five years, increasing patient access to affordable treatments." The Generic Drug User Fee Act (GDUFA II), which is authorized by the legislation, "builds on the experiences of the last five years through increased transparency and communication, a more efficient review and approval process, and additional resources dedicated to increasing timely review of generic and biosimilar applications."
FDARA provides for eight-month priority review of applications for a generic drug that lacks sufficient competition, expedites the review and development of certain generic therapies, and provides a 180-day exclusivity to incentivize generic competition to older, off-patent branded drugs, among other provisions.
We were shepherded by our Washington, DC-based advocacy firm, whose staff learned our unique set of interests, lined up the right meetings for us, and kept us apprised of the key steps in the process of bringing FDARA to fruition.
As we move past FDARA (until the next reauthorization cycle), PBOA is in a position to advance a more proactive agenda, bringing together the voices of the CMO/CDMO sector to develop ideas that can strengthen our industry, improve quality, and bring effective medicines to patients.