The Pharmaceutical segment includes human health pharmaceutical and vaccine products. For a further discussion of sales of the Company's products, see Item 7. " The total annual industry fee has been set at $2.8 billion. The Company is unable to predict the likelihood of changes to the ACA. A number of states have passed pharmaceutical price and cost transparency laws. In 2020, drugs were added to the NRDL through double-digit price reductions. Financial Statements and Supplementary Data," Note 10. " Contingencies and Environmental Liabilities" below. Pre-marketing vaccine clinical trials are typically done in three phases. The applications are based on results from the Phase 3 VICTORIA trial. Selumetinib is being jointly developed and commercialized with AstraZeneca globally. The FDA set a PDUFA date of July 18, 2021. Merck plans to share data from COUGH-1 and COUGH-2 with regulatory authorities worldwide. A supplemental application was also submitted to the EMA and is currently under review. Business — Research and Development" above. The Company faces intense competition from lower cost generic products. In 2020, the COVID-19 pandemic impacted the Company's business in numerous ways. For all these reasons, sales within emerging markets carry significant risks. Any of these events could result in substantial costs. The Company does not assume the obligation to update any forward-looking statement.
