FDA Drug Approvals off the Charts for 2014

New Medications Meet Unmet Patient Needs

The Food and Drug Administration’s approval of 41 novel new drugs in 2014 made it a banner year for the pharmaceutical industry. The class of 2014 included biologicals, drugs that treat cancer and infectious diseases (bacterial, fungal, parasitic and viral) and therapeutic drugs.

The company leading the pack is AstraZeneca, which received four approvals from the agency’s Center for Drug Evaluation and Research. Lilly scored two approvals.

“Although our annual summary reports the quantity of novel new drugs that we approved, our main focus is on the unique qualities of many of these new drugs, their contributions to enhanced patient care, and the various regulatory tools CDER used to help ensure their safe and efficient development and approval,” Dr. Janet Woodcock, the center’s director, said in a report titled “Novel New Drugs 2014 Summary,” which was published in January 2015. “As you will see, 2014’s field of novel new drugs will offer much to patients in need.”

Woodcock said more orphan drugs were approved this year than ever before – good news for those with rare disorders and unusual diseases. In addition, drugs approved under the Priority Review process totaled 61 percent. Priority Review places the drug on the review schedule within six months instead of 10. Forty-one percent of the total were Fast Track designees, meaning products that had the potential to meet previously unmet medical needs. They were granted a preliminary review before the respective developer submitted a final application.

Breakthrough therapies amounted to 22 percent of the total; another 20 percent were Accelerated Approval drugs.

“Each year, CDER approves hundreds of new medications, most of which are variations of previously existing products, such as important new dosage forms of already approved products, or cost-saving generic formulations,” Woodcok said. “However, products in a small subset of these new approvals, which we refer to as novel new drugs, are among the more truly innovative products that often help advance clinical care to another level.”

The liver is highly affected by Hepatitis C.

AbbVie’s hepatitis C treatment, called Viekira Pak, is predicted to reach rock-star status in 2015 because of a pricing contract with Express Scripts, according to Forbes. In a “Pharma & Healthcare” article on its Web site, contributor Bernard Munos writes Viekira Pak might result in lower consumer costs in an industry ridiculed for ripping off patients.

“In the last 15 years, even marginal drugs that brought tenuous benefits to patients could command extreme prices since there were few options,” Munos says. “As Viekira Pak is reminding us, the future may not be so easy.”

The largest manager of prescriptions in the nation, Express Scripts, agreed to require its roster of 25 million patients to take the AbbVie pills rather than the more-popular regimen manufactured by competitor Gilead. Another article on the Web site Pharmagellan describes the discounting as a violation of an industry commandment.

“Thou shalt not engage in a price war out of the gate when thou launchest a new drug,” according to the article.

Whether the agreement does or doesn’t violate a commandment, it sets a precedent for “Big Pharma.”

“By negotiating a lower price, AbbVie has ensured that most Express Scripts patients won’t be able to choose its ‘better’ competitor, period – and all of a sudden, it’s back in the game, in an enviable position,” the article states. “Unless Gilead wants to run a long, expensive trial proving that its once-daily drug is actually more clinically effective…the company must either settle for a smaller piece of the pie (Viekira Pak-ineligible patients and those who fail Viekira Pak), or offer a comparable discount to regain equal access.”