Is the National Priority Voucher Good News for RX Costs?
The drug approval process is a lengthy one that can take anywhere from months to years, but as the COVID-19 pandemic proved, it’s not always possible to wait that long for emergency or essential medications.
To address this problem, the Food and Drug Administration (FDA) has created a new pilot program called the National Priority Voucher. It holds some promise and could make it easier for pharmaceutical companies to assist with public health while increasing their profits at the same time.
There are some potential drawbacks, however, that have generated criticism. Learn more about the National Priority Voucher and what it could mean for your medication costs. Or read more on FDA changes and how they could raise medication costs.
What Is the National Priority Voucher?
This FDA pilot program aims to provide a faster review process of certain biological drugs and products deemed to be national healthcare priorities. The goal is to reduce the review process, enabling people to access life-saving medications as quickly as possible.
Currently, getting a drug approved takes between 10 and 12 months. With the National Priority Voucher, the same drug could be approved in one to two months. The pharmaceutical companies that create the needed drugs would then receive a voucher that they could use to speed up the review process of another medication.
Companies would apply for this program by submitting draft labeling along with chemistry, manufacturing, and controls information. A multidisciplinary team would review all of the applications and decide on the ones that most closely match national health interests.
Those companies would receive a non-transferable voucher. They could use it for a specified product or leave it “undesignated” until they come up with a new drug.
Potential Benefits of the National Priority Voucher
The National Priority Voucher can incentivize pharmaceutical companies to work on medications that can impact the lives of millions in the United States. Because the review process is faster, the drugs can make it into people’s hands sooner.
The program encourages domestic drug manufacturing, which aligns with national efforts to reduce dependence on foreign companies or supply chains. In an increasingly divided world, where instability and conflict are issues for a large number of countries, not depending on other nations is a huge draw.
The National Priority Voucher also offers the chance for enhanced communications between pharmaceutical companies and the FDA as they go through the review process. This can offer a quicker resolution to any issues that might arise.
By encouraging competition as a result of giving many pharmaceutical companies the chance to bring essential medications to the market, the program also strives to lower drug prices.
Potential Drawbacks of the National Priority Voucher
There are some drawbacks that have critics worried about this program. One of them is that larger companies might get priority over smaller ones for these vouchers. They have more resources, allowing them to bring a medication up for review more rapidly. Since vouchers are not unlimited, this could result in a lack of competition and, subsequently, higher prices.
There could also be a reliance on incentives, leading pharmaceutical companies to only work on medications that would meet the government’s criteria. The voucher program could mean that less attention is placed on medications for less-common conditions — a problem that is already happening.
Additionally, the program allows companies to submit earlier data. It may not offer the full picture of the drug, or it could leave safety concerns unanswered.
For pharmaceutical companies, speed will be a priority, not cost-efficiency. Each company will want to be the first to bring a specific type of drug for review. The additional costs that the company incurs will be passed down to the consumer, hiking prices for everyone.
How the CNPV Pilot Differs from Other FDA Fast-Track Programs
The FDA already offers several expedited review pathways, but the Commissioner’s National Priority Voucher is unique. Unlike Priority Review, which shortens review times to six months, or Fast Track Designation and Breakthrough Therapy Designation, which focus on serious or life-threatening conditions, the CNPV aims to reduce review time to just 1–2 months for drugs and biologics that meet U.S. national health priorities.
Another standout feature is its tumor board–style review process. This brings together a multidisciplinary team to evaluate applications in a highly collaborative format. This allows issues to be found and resolved quickly, rather than through the traditional back-and-forth of written correspondence.
Because the CNPV is a pilot program with limited participant slots, its impact on overall drug pricing and access remains to be seen. However, its potential to transform the approval timeline for critical treatments sets it apart from any other FDA initiative to date.
Affording Your Medications
The National Priority Voucher is not an option that will do much good for Medicaid recipients or those who don’t have insurance. Drug costs are likely to increase. To be able to afford your medications, consider prescription assistance programs.
These programs allow you to receive all of the discounts you may be eligible for. They work with pharmaceutical companies, insurers, and pharmacies to provide prescriptions at significantly lower rates.
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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