A U.S. president can significantly impact policy and agencies, which can have a huge effect on industry and the market. As we prepare for another Trump presidency, it’s important to consider potential changes for stakeholders within the healthcare sector.
During the COVID-19 pandemic, large pharmaceutical companies boomed with the release of vaccines. However, after COVID cases were controlled, many companies have struggled to pivot and adapt after scaling up to produce vaccines. During the first Trump presidency, the Trump administration acted to lower drug prices [1] but was blocked by the pharmaceutical industry [2]. It is likely that Trump would continue this approach into his second presidency, which is something drug companies should be aware of. If Trump appoints RFK Jr. to oversee health and food policy, there could be huge changes in drug approval policies, which could lead to more stringent reviews of vaccine safety and slower approvals [3]. This could cost pharma companies more time and money in an already challenging period. EMMA International is here to help with your vaccine approval and post-market maintenance during the transition to a new presidency.
However, for drug companies that aren’t producing vaccines, and medical device companies, there may be less regulatory action from the FDA. During the first Trump presidency, the number of FDA warning letters declined [4]. Fewer FDA regulations could stimulate innovation and give companies more freedom. If you need some extra help, EMMA can step in and support with staff augmentation services. Overall, it’s difficult to predict what could happen to the pharmaceutical industry during the new presidency, but with new changes, EMMA International is here to support you and your organization with turnkey solutions to your quality, regulatory, and operational challenges.
EMMA International is here to provide full-circle solutions to support your company. Give us a call at 248-987-4497 or email us at info@emmainternational.com to learn more about how EMMA International can take the stress out of quality and regulatory compliance!
[1] FDA (2019) Trump Administration takes historic steps to lower U.S. prescription drug prices, Retrieved on 8 November 2024 from:
https://www.fda.gov/news-events/press-announcements/trump-administration-takes-historic-steps-lower-us-prescription-drug-prices
[2] Armour (2024) How health care could change under the new Trump administration, Retrieved on 6 November 2024.
https://www.npr.org/sections/shots-health-news/2024/11/06/nx-s1-5181861/2024-election-trump-kennedy-health-care
[3] Diamond, Weber, Sun, and Roubein (2024) How much influence could RFK Jr. have over vaccines in Trump’s government?, Retrieved on 8 November 2024 from: https://www.washingtonpost.com/health/2024/11/08/rfk-jr-vaccines-fda-trump-health-policy/
[4] Piller (2019) Exclusive: FDA enforcement actions plummet under Trump, Retrieved on 8 November 2024 from: https://www.science.org/content/article/exclusive-fda-enforcement-actions-plummet-under-trump

EMMA International

EMMA International

EMMA International Consulting Group, Inc. is a global leader in FDA compliance consulting. We focus on quality, regulatory, and compliance services for the Medical Device, Combination Products, and Diagnostics industries.

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