2017 looks brighter for efficiency of FDA-drug approval process

Although 2016 saw the Food and Drug Administration approve only 22 new drugs compared with 45 approvals in 2015 and the lowest tally since 2010, many in the pharmaceutical arena remain optimistic that this year will see a reversal of that trend.

The passage of the 21st Century Cures Act last winter and the number of drugs already approved by the FDA this year, they said, give hope to 2017 being a banner year for innovative new therapies hitting the market.

“Cures is very long and broadly covers a good deal of ground,” Mark Senak, a lawyer and author of the blog Eye on FDA, said earlier this year about the legislation that President Obama signed into law in mid-December. “[It will] speed up the pathway for approvals, particularly for rare diseases, and reduce the regulatory burden industry faces in getting new products into the marketplace.”

The bill, which allocates nearly $5 billion for medical research, also gives the FDA about $500 million to help it develop tools to improve the efficiency of the drug-approval process. It also encourages the FDA to consider pieces of information in its approval process in addition to traditional clinical trials, including what lawmakers call “real world evidence,” as well as the biomarkers often used in studies in place of outcomes that are more difficult to measure.

Many of the branded drugs that get approved this year are expected to be first-of-their kind medications and therapies that provide patients with more effective alternatives.

Last month, for instance, the FDA approved Ocrevus, the first treatment for patients with relapsing multiple sclerosis — the most common form of the disease. In addition, the drug, developed by Roche’s Genentech unit, has shown that it can slow the progression of primary progressive MS, a more severe type of the disease.

“The current research pipeline shows that the future of biopharmaceutical innovation has never been more promising for patients in need,” Pharmaceutical Research and Manufacturers of America director of public affairs Andrew Powaleny said in January. “There are currently more than 7,000 medicines in development, of which more than 1,700 are in phase III trials — meaning they are in late-stage studies.”

Meanwhile, this year is expected to see a host of new generic medications emerge as manufacturers take advantage of expiring patents on several highly prescribed drugs, including Pfizer’s erectile dysfunction drug Viagra; Teva Pharmaceuticals’ asthma medication Proair HFA; Merck and Schering Plough’s cholesterol drug Vytorin; and Bristol-Myers Squibb’s HIV medicine Reyataz.

According to the pharmacy benefits management company Corporate Pharmacy Services, 17 new generics are expected to get FDA approval this year with another 13 slated for approval in 2018.