Teva sees room for growth with FDA communications and complex generics, COO says
While embroiled in legal battles, generic drug giant Teva Pharmaceuticals is hoping to turn a corner with the FDA in improving their communications and focus on complex generics.
“The concern we have as an industry as we move into a new era of science where a lot of the products that are coming off patent are more complicated and fall into this sort of complex generics category — we think it’s up to a third of the [generic] products altogether — we need to figure out how to get those products to market,” Christine Baeder, SVP and chief operating officer at Teva, told Endpoints News in a phone interview.
A recent white paper authored by AEI resident scholar Alex Brill and commissioned by Teva estimated that delays in the approvals and launches of just 7 complex generics in the US results in annual lost savings of about $1.3 billion. “The FDA and other stakeholders have made efforts to facilitate a more robust complex generic marketplace, but these have thus far resulted in process improvements more than outcome gains,” Brill wrote.
Part of the problem is the level of scientific dialogue between the FDA and generic industry, which has to ramp up because of the way these complex generics are manufactured and developed, Baeder said. Product-specific guidances from FDA “are helpful to a point,” she noted. “Often the FDA will look at a guidance and redo it, and then when they redo it, they retroactively apply it, so any work you may have done is sort of lost, or the goal post is moved. So that seems like maybe not the best approach.”
Christine BaederBaeder also explained how European and Canadian drug regulators often engage in discussions with the sponsor when there is a question or a problem. But in the US, “FDA’s main vehicle for communication is CRLs [complete response letters] or other written documents that don’t necessarily involve that dialogue — and you lose months and months of development.”
There needs to be a better process for the immediate, transparent and clear scientific communication, she said.
Teva is part of ongoing industry-FDA negotiations on the next iteration of the Generic Drug User Fee Amendments (GDUFA III), which will kick into effect in September 2022. But the bulk of those negotiations are kept confidential so it’s unclear as to what exactly industry is fighting to include in the package, which also must win congressional approval.
“The unintended consequence of some of the lack of [FDA] transparency is that people with jobs like mine have to make a decision with very imperfect information on when we might get an approval and therefore when should I invest in the capital equipment to make that product,” she said.
The FDA in recent years has raised concerns about the growing number of generic drugs that win approval but never launch, often because the market is no longer viable or the generics company has shifted its strategy or doesn’t have supplies on hand.
“One of the major reasons is that you don’t necessarily know when you’re going get approval,” Baeder said. “If I look at the generic version of the EpiPen, which Teva launched after 10 years of working on the approval — were we ready? No. We had no idea it was going to come, so it took us a certain amount of time to scale up.”
On the EpiPen example she also noted that Teva didn’t build the necessary inventory to immediately launch into the US market because the company had built inventory several times, she noted, and “had to throw it away.”
“It’s very hard to know where you are in the FDA’s approval process — in a perfect world, we would want to sit with the FDA as a partner and have complete clarity to ensure we’re bringing generics to patients once there’s an approved,” she noted.
But as far as Teva’s ongoing legal troubles — the company has been charged for price fixing, defrauding Medicare and its involvement in the opioid epidemic — Baeder declined to comment.
