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Trump Disses FDA as “Slow and Burdensome”

Trump Disses FDA as “Slow and Burdensome” | Pharma Industry Regulation |

President Trump on Tuesday called on the Food and Drug Administration to speed the approval of drugs to treat life-threatening diseases, deriding the agency’s current process as “slow and burdensome.”


In an address to a joint session of Congress, Trump said that the FDA approval process “keeps too many advances … from reaching those in need.”


He noted that his speech was taking place on Rare Disease Day and cited the case of Megan Crowley, who was diagnosed with Pompe disease, a rare condition that leads to muscle and respiratory damage, and who was among the first lady’s guests during the joint session of Congress.


“Megan’s dad, John, fought with everything he had to save the life of his precious child,” Trump said. “He founded a company to look for a cure, and helped develop the drug that saved Megan’s life. Today she is 20 years old — and a sophomore at Notre Dame.”


“If we slash the restraints, not just at the FDA but across our government, then we will be blessed with far more miracles like Megan,” Trump said.


The president has harshly criticized the drug industry in the last year and at times supported policies drug makers loathe, such as allowing Medicare to more directly negotiate the prices it pays for prescription drugs. Since meeting with industry leaders earlier this month, however, Trump has spoke more about the need to speed drug approvals.

Pharma Guy's insight:

One solution to alleviating FDA’s “slow and burdensome” approval process and getting potentially life-saving drugs to patients like Megan is "Right to Try" laws that would allow people with fatal illnesses to gain access to experimental medicines, even though they are not enrolled in a clinical trial. Do you think this is a good idea? Why? Why not? Take my survey:

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