A four-year drug approval backlog at the FDA is preventing cheaper generic drugs from being approved on time. According to a recent drug review report published by the FDA, there are currently over 4,000 generic medication applications awaiting approval as of July 2016. This accumulation of thousands of treatment submissions has now pushed the FDA drug approval process to an average of 47 months.
Back in 2012, the government-imposed fees on generic drug manufacturers to help hire new employees and obtain modern information technology systems that were meant to speed up to the FDA’s drug approval process. However, $1 billion in fees later, the FDA has only approved half of the drugs that were awaiting approval in 2012. So what is taking so long? To understand this issue, you have to break down how the FDA grants exclusivity rights to pharmaceutical companies.
Medication Patent Protections and Exclusivity Rights
Generics in the US are regulated by the FDA’s drug approval process to ensure the safety and effectiveness of treatments. But before generic versions of treatments can be made, the protections on the branded drug must expire.
When pharmaceutical companies develop new drugs, they guard their research on the new active ingredients or formulations with a patent for up to 20 years. While this may seem like a long time, keep in mind that it can take drug companies up to 12 years to take new treatments from the research and development stage to the pharmacy counter. Once the FDA approves the new drug through a lengthy application process, it grants the company exclusive rights to market and sell the treatment to patients. The exclusivity rights vary by drug type and the following factors:
• Orphan Drug Entities (NCE): For new orphan drugs or medications that treat rare medical conditions, the pharmaceutical company can hold the exclusive rights to market and sell a product of up to seven years. These rights essentially prevent other companies from developing or marketing the same drug during this period.
• New Chemical Entities (NCE): For drug makers who introduce new chemical entities or medications that contain completely new molecules that are not available in any other treatment, the FDA can grant an exclusive right for up to five years.
• Pediatric Exclusivity (PED): The FDA gives pharmaceutical companies an additional six months of exclusivity rights and patent protections for medications that are safe for children. This extension is only granted if the manufacturer presents lengthy research and clinical trial evidence that demonstrates that an existing approved drug is effective at treating children.
• Other: If the molecule formulation is changed on an existing active ingredient, the FDA can grant drug makers an additional six months to an existing patent and exclusivity rights to sell and market the medication.
After the exclusivity rights expire, other pharmaceutical companies can submit an application to send a drug through the FDA drug approval process in order to grant rights to make and sell a less expensive version of the drug containing the same active ingredient(s). However, acquiring the rights of patents and receiving approval to sell generic drugs can take decades. For example, branded erectile dysfunction treatment Viagra was approved by the FDA back in 1998, yet Pfizer has fought lengthy legal battles to extend protections on this drug. There are currently no generic versions of Viagra simply because it is a blockbuster drug that has made Pfizer over $1.9 billion in sales, according to internal company reports.
The FDA’s drug approval process helps make drugs safer, but the backlog of generic approvals is making some drugs less accessible.
Uphill Push to Speed Up FDA Generic Approvals
Critics are pressuring the FDA and other pharmaceutical companies to improve access to more affordable treatments. The counterargument for this issue from the pharmaceutical industry is that it simply takes an army and billions to manufacture new drugs that are approved by the FDA. According to Tufts Center for the Study of Drug Development, the estimated cost to bring a new drug from the research stage to the consumer is around $2.6 billion in 2016.
At such an expense, it is no surprise that pharmaceutical companies fight decade-long legal battles to prevent generics from being developed. This issue, of course, brings up ethical concerns over how much power these companies have at slowing down the FDA generic approval process. For the patient, it is best to keep demanding generics treatments from doctors, searching for manufacturer copay-assistance programs, and using sites like HelpRx to lower the price of patent-protected branded drugs by up to 75% off pharmacy retail though drug coupons.