The Lupin Pharmaceuticals team at Baltimore was really pleased to host Ambassador Sandhu and his senior staff. It was an engaging dialogue with the Ambassador and senior staff from Commerce and Science & Technology. He was impressed with the Lupin story in helping bring medicines to the US and becoming the third largest company in the U.S. by volume of prescriptions. He was empathetic to our needs as we help shape a more sustainable generics industry in the US. We discussed the need for a supportive ecosystem of policies, regulations, and market structure that is needed for companies like Lupin to help address the many challenges to market access in the US.
We discussed the support that the generics industry has provided to the regulatory system and the FDA. The user fee programs and the billions contributed by industry to FDA have resulted in trillions in savings to patients.
Over 10 years of the Generic and Biosimilar programs at FDA, the generic and biosimilar industry has provided more than $4 billion to support review and approval of lower-cost treatments for American patients. The result is more than $2 trillion in savings to patients – including $469 billion from new generics and more than $12 billion from biosimilars – and a dramatic increase in patient access to life-saving treatments.
We discussed key policy issues including the several challenges to Market Access. The BLOCKING Act, a potential legislation in the works, is likely to substantially weaken the industry’s 180-day period of exclusivity, and has been a perennial threat. As an industry, we continue to strive to make our case heard on the Hill as The BLOCKING Act would fundamentally change the 180-day incentive and harm generic manufacturers who are actively pursuing FDA approval. The result would be fewer generic drugs introduced into the market and less competition– undermining the potential for patient savings and not fully maximizing the value of Hatch-Waxman.
We discussed the industry and Lupin’s response, in particular, to the pandemic. As a #3 player in the market, Lupin’s supply chain has been resilient and has endeavored to ensure American patients can access the medicines they need, when they need them. And despite stresses, including unprecedented demand for certain products and shipment price increases and delays, Lupin has invested in building resilience and redundancy in the supply chain to ensure the availability of its medicines.
Without access to their generic prescriptions, at 90% of the volume of prescriptions, so many more people would have faced even greater vulnerability. At Lupin, we were proud to deliver and benefit patients in need.
We look forward to working collaboratively and closely with the Ambassador and his team.