New FDA Commissioner Scott Gottlieb has hit the ground running, particularly in the realm of generics competition.
On Tuesday, his agency announced two new initiatives designed to foster more competition for drugs that have lost patent exclusivity.
The first was to publish a list of all the drugs that have lost patent protection but that lack any real competition. At the same time, Gottlieb made a step towards honoring his pre-confirmation promise to expedite the generics approval process, which has suffered from a major backlog for years.
Why make is this a priority?
Look no further than Martin Shkreli’s 5000 percent price hike on Daraprim (pyrimethamine), which makes the list, or the Mylan EpiPen saga. Both products had been on the market for decades, but as competition died down, the companies’ executives saw an opportunity to ramp their prices up.
It typically takes years for other companies to gain an abbreviated new drug application (ANDA), the relevant path for FDA approval of generics. Add to that the standard manufacturing and supply chain logistics and you give the Mylan’s of the world a wide window to capitalize on their price hikes — at the expense of patients and insurers.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
That’s where the list comes in. The agency hopes to encourage generics companies to create a second or third product for these unsaturated markets.
When it comes time for approvals, Gottlieb’s second initiative will work to streamline the process for generic products with fewer than three ANDAs approved and no blocking patents on the original drug.
According to FDA, competition from generic drugs has saved the health care system approximately $1.67 trillion in the last 10 years alone. But for it to really make an impact, its studies suggest the market needs three or more competing products to significantly lower prices.
To the end, the agency is taking a very active approach. Tuesday’s initiatives follow the unveiling of an action plan last week that aims to close regulatory loopholes that brand-name manufacturers exploit to delay the launch of generic competition.
“We know that sometimes our regulatory rules might be “gamed” in ways that may delay generic drug approvals beyond the time frame the law intended, in order to reduce competition,” Gottlieb wrote in an FDA blog post. “We are actively looking at ways our rules are being used and, in some cases, misused.”
One example he gave is brand-name manufacturers withholding their products from those seeking ANDA approvals. Companies typically need 1,500-3,000 doses of the original product to prove bioequivalence, but through strategic distribution deals and other strategies, brand-name manufacturers can make it very hard for the competition to acquire those samples.
Something clearly needs to be done, but FDA will need to proceed with caution. Just yesterday Bloomberg published a story about the disconnect between brand name and generic drugs, discussing the negative impact this can have on patients. There’s no room for standards to slip further. What’s more, drugs are increasingly complex; from their convoluted supply chains to the different delayed-release formulations.
A critical balance needs to be struck between reliability, cost-efficiency, and speed.
Photo: Martin Barraud, Getty Images
