The Generic Pharmaceutical Association (GPhA) has offered three key recommendations to Congress on how to work with the US Food and Drug Administration (FDA) to increase generic competition, according to a new report issued Tuesday.
First, like Hillary Clinton and many others in the past, GPhA is calling on Congress to take action to reduce the backlog of abbreviated new drug applications (ANDAs) awaiting FDA approval. The association says Congress should work with industry to encourage a more timely FDA review of the more than 3,800 pending ANDAs.
In reauthorization negotiations of the Generic Drug User Fee Amendments of 2012 (GDUFA) – which sets out the industry payments to FDA partly to ensure the timely review of ANDAs -- GPhA previously said FDA is falling short of its goal in reducing that backlog. FDA, however, defended itself by noting a steep spike in the number of new ANDAs filed by industry. Under GDUFA, FDA said it planned to receive about 750 ANDAs annually, though in 2014 the agency saw companies file almost 1500 applications.
Still, GPhA said in a statement on the GDUFA meeting from June: “Given the sluggish pace of reviews and the steadily growing backlog, it is especially confounding that the FDA still has $277 million in unused funds from the generic industry that could be applied to site inspections or approvals.”
Abuse of FDA Programs
In addition to the ANDA backlog, GPhA is calling on Congress to investigate “the abuse by some brand drug companies of FDA programs designed to protect patient safety.”
More specifically, GPhA points to programs, such as the Risk Evaluation and Mitigation Strategies (REMS), which have been misused to prevent the entry of some generics to the market.
One recent example of such a case of misuse is with Turing Pharmaceuticals, which has employed a restricted distribution program to thwart generic competition by not allowing potential competitors to obtain samples of the drug that are necessary to conduct the appropriate testing to bring generics to market.
Clinton also previously called on the Federal Trade Commission to take action against Turing to see if this amounts to anti-competitive behavior.
“This misuse comes at a cost of $5.4 billion annually to our health system,” GPhA says, citing a separate analysis conducted in 2014 by Matrix Global Advisors.
And although biosimilars don’t fall under the category of generics, GPhA is calling on Congress to further encourage FDA to increase competition for biologics by implementing regulations and policies for approving biosimilars.
Senators in September grilled FDA’s Janet Woodcock over the delay in releasing a number of guidance documents linked to biosimilars – particularly on interchangeability and labeling. Woodcock, however, cautioned that FDA has to be cautious with its initial approvals of biosimilars in the US (only one has been approved so far) so patients are safe and the biosimilars are proven to be effective.
Similarly, GPhA says FDA has to support a biosimilar naming system and interchangeability policy that “encourages competition from safe, more affordable” biosimilars.
In addition to the recommendations, the report also revealed that generic drugs now account for 88% of all prescriptions dispensed in the US, while accounting for only 28% of total drug spending.
“Generic drugs were responsible for $254 billion in health system savings in 2014, bringing the total savings over the last 10 years to $1.68 trillion,” GPhA says.
The report also for the first time includes a state-by-state breakdown of generic savings.