New FDA Rules Could Raise Medication Prices & Slow Access
The US Food and Drug Administration (FDA) has made sweeping changes recently to how it approves medications. This comes on the heels of a reduction in the workforce with thousands laid off.
Although regulatory changes could be beneficial in some instances, especially when it comes to pharmaceutical transparency, the reduction in staff and complications these processes involve could also lead to higher costs and slower access for consumers. Learn more about the new FDA rules and what they could mean for you.
New FDA Regulatory Changes
The FDA is placing a significant focus on raising manufacturing standards. Now that there are added compliance steps and an increase in evidence requirements to demonstrate that medications are safe for consumption, drugs require a longer testing process at the trial level. Given the increased evidence to review, the FDA review will require more personnel, which is challenging at a time when the agency is operating at an all-time staffing low.
To address this, the new Commissioner’s National Priority Voucher (CNPV) pilot program, announced in June 2025, will accelerate the approval of drugs and biologics that meet certain national priorities. Essentially, giving some companies vouchers that speed up approvals to one-to-two months.
There is concern that the FDA’s use of this pilot program to expedite review processes for companies offering more affordable rates could not only impact safety but also enable companies to exploit loopholes in the system. It could also put a strain on competition, impacting prices and the ability of people to access the medications they need.
Smaller pharmaceutical companies, such as those specializing in generic medications, could face significant challenges due to the need for higher manufacturing standards. This could further discourage competition because manufacturers may not want to venture into newer fields and may instead stick to drugs that have already been developed.
One of the areas that is most affected by the FDA regulatory changes is the development of vaccines and biologics. There is also a growing focus on creating medications for rare diseases, but many worry that the push could prompt pharmaceutical companies to focus solely on those issues.
How the Changes Impact Consumers
For the market to regulate itself, it requires healthy competition. If only the largest pharmaceutical companies can afford to jump through all the regulatory hoops, then competition can be whittled down. The remaining companies can price their drugs as they like, and consumers don’t have an option other than to purchase from them.
There will be fewer medications on the market because all of these regulations could prevent companies from pursuing innovation. Having drugs that only come from one source prompts worries about access. If anything in the manufacturing process goes wrong, consumers are left with no alternative providers.
People who can afford fast and high-quality care will have easier access to the medications, while those on Medicaid could struggle to receive the drugs they need. This widens the country’s healthcare gap even more.
Finding Price Solutions
One of the options consumers have for dealing with these regulatory changes is to consider prescription assistance programs. These can help you find discounts and other ways of saving money on the prescription medications you need.
Prescription assistance programs work closely with pharmaceutical companies and government agencies to find the most appropriate benefits for each individual. They assist with treatment adherence by preventing patients from having to skip or halve doses, which leads to better outcomes for both consumers and the healthcare system.
There are different eligibility criteria you may have to meet for these programs. Your insurance status, income, and a few other factors can play a role.
In addition, the Medicare Price Negotiation Program has been introduced to address high drug costs directly. As part of the Inflation Reduction Act (IRA), this program allows Medicare to negotiate the prices of certain medications, which is expected to lower costs for seniors. For more details on how the program works, you can read about Medicare’s Price Negotiation Program and how it can help seniors save on prescription costs.
Get Affordable Access to Prescription Medications
Simplefill is a full-service prescription assistance company that researches, qualifies, and maintains patients’ enrollment in all sources of assistance available to them.
Apply today by calling 877-386-0206. A caring Simplefill representative will contact you within 24 hours to discuss your application and, if qualified, enroll you in the program.
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