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Trump’s FDA: Is the US regulator being steered by the President?

Published on 09/09/19 at 12:27pm

FDA activity has fallen under Donald Trump, with the number of warning letters issued by the regulator dropping by a third since the President took office, according to a recent article published in Science. Louis Goss asks whether the current administration is affecting the direction of the organisation, or is it mostly independent of federal oversight?

US presidential candidate Bernie Sanders pledges to allow Americans to import drugs from Canada

Democratic presidential candidate Bernie Sanders has said he will, on his first day in office, allow for the importation of prescription drugs from Canada to the United States.

“On day one of my administration, I will direct the Secretary of Health and Human Services and FDA Commissioner to allow pharmacists, wholesalers and patients to purchase FDA approved prescription drugs from Canada,” Sanders said.

“There is no rational reason why insulin and other life-saving medications should cost ten times more in the United States than Canada.”

Top Ten most popular articles on Pharmafile.com this week!

This week’s most popular story covered news of Trump’s claims that he will introduce an executive order to ensure the United States pays the lowest drug prices in the world. The claim comes amid lively debate around drug pricing in the United States.

Across the pond, the UK Government said it would give boys the HPV vaccine in an effort to tackle cancers. The NHS also said it would try out a subscription style payment model for antibiotics in seeking to tackle the global crisis of antimicrobial resistance (AMR).

Trump administration drops law to end rebates for PBMs

The Trump administration has dropped plans to introduce a law which would end rebates on prescription drugs under Medicare.

The Trump administration has said it is abandoning plans to bring in a law which would eliminate the ‘discount safe harbours’ which make prescription drug rebates possible in the United States.

Currently, drug companies pay retrospective ‘rebates’ to pharmacy benefit managers (PBMs) and others in the supply chain who buy drugs at the wholesale list price.

US Judge blocks Trump administration law requiring pharma to include prices in TV ads

A judge has blocked the Trump administration from enacting a law that would require pharmaceutical companies to include the prices of their drugs in TV ads.

On 8 July 2019, District Judge Amit Mehta in Washington, DC ruled in favour of pharma giants Amgen, Eli Lilly and MSD in preventing the Department of Health and Human Services (HHS) new law from taking effect.

Trump says executive order will ensure US will pay lowest prices in the world for drugs

President Donald Trump has said that the White House is working on a ‘favoured nation clause’ to ensure the United States pays the same price for pharmaceutical drugs as those countries that pay the lowest prices in the world.  

FDA sharpen focus on pharmaceutical companies under Trump

The overall number of warning letters being sent out by the FDA has dropped under President Donald Trump, according to analysis posted in Science. However the number of warnings sent to pharma firms has increased.

According to research published in Science, the total number of warning letters sent out by the FDA has dropped by a third under President Donald Trump, with 1033 letters sent out since Trump’s inauguration, compared to 1532 under Barack Obama over the same period of time.

Read the July/August edition of Pharmafocus online now!

The latest monthly edition of Pharmafocus, the July/August issue, is available to read for free online now!

The UK remains split right down the middle as the Brexit crisis rolls on and on, and while we have been side-tracked from one political wedge to focus on another – the race to become the new leader of the Conservative Party, and, ultimately, the next Prime Minister – there is still one issue that never fails to heal the divide: the defence of the NHS.

Drugmakers sue Trump over prices in TV ads

Amgen, Eli Lilly and MSD have sued the Trump administration to try and block measures to force pharma companies to include prices in TV ads.

Three of America’s biggest drugmakers filed a lawsuit against the Trump administration over the Department of Health and Human Services (HHS) ruling to force pharmaceutical companies to list the prices of their drugs in adverts on TV.

Gilead will give 11 years’ worth of PrEP drugs to those at risk of HIV after 'discussions' with Trump

Gilead Sciences has agreed to donate 11 years’ worth PrEP drugs for up to 200,000 individuals each year, following “discussions between the Trump Administration” and the California firm.

Gilead Sciences will give preventative HIV drug Truvada to uninsured individuals who are at risk of being infected with HIV, Health and Human Services Secretary Alex Azar said.

The agreement will last until at least the end of 2025 and may continue through to December 31 2030.

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