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Randi Hernandez was science editor at BioPharm International from September 2014 to May 2017.
Trump met with pharma manufacturers and makes a statement focused on domestic manufacturing, FDA approvals, and drug pricing.
In a short, televised statement on Jan. 31, 2017, President Donald Trump spoke with leading biopharma company executives about inefficiencies at the FDA, pharmaceutical manufacturing jobs in the United States and abroad, and “foreign price controls on drugs.” The wide-ranging statement, however, did not provide insight about how the administration plans to fix the problems identified including patient access to experimental drugs, “astronomical” pricing for drugs in the US market, faster drug approvals, foreign price controls, and offshore manufacturing. Trump’s remarks came prior to a meeting with Celgene CEO Bob Hugin, Merck CEO Ken Frazier, President and CEO David Ricks from Eli Lilly, Novartis CEO Joe Jimenez, and members of the trade group PhRMA.
Trump said the government must "streamline the process" of drug approvals and make the process "much faster" and referenced how terminally ill patients should have access drugs in that are still in development stages. Expediting approvals will be a major task for FDA, which currently has hundreds of vacant positions and faces a federal hiring freeze initiated by the Trump administration last week. In addition, an executive order issued on Jan. 30, 2017 requires federal agencies to remove two regulations with the introduction of any new regulation. According to NPR, Trump said at least 75% of all regulations will be eliminated.
It is "unfair what other countries are doing to us," said Trump in the statement, and that foreign companies must "pay their fair share" for US-manufactured drugs so that US companies have more money to innovate. He also mentioned "ending global freeloading", saying that “foreign price controls reduce the resources of drug companies to finance R&D.”
Trump urged the pharma executives, "you have to get your companies back here," suggesting that biopharma should return operations to the US. Prior to winning the Presidency, Trump suggested a repatriation tax of 10%.
PhRMA President and CEO Stephen Ubl said in a statement that the meeting was positive and that reforming the tax code, moving towards a value-based drug pricing system, removing outdated regulations, and creating better trade agreements would benefit the industry. “We believe if these policies are enacted, it will translate to up to 350,000 new jobs over the next 10 years as a result of growth in the biopharmaceutical industry,” Ubl said.