The U.S. Food and Drug Administration approved the most number of first-of-a-kind drugs in 2015, pushing the annual count of new drugs in the country to a 19-year high.

Last year, the regulatory agency approved 45 drugs with ingredients sold for the first time in the U.S., surpassing 2014’s total of 41 drugs approved. It is the highest tally since the 53 drugs approved in 1996.

Last year’s FDA drug approvals – deemed a marker of government efficiency in reviewing novel medicines and therapies and industry innovation – reflected the movement toward treating rare, hard-to-treat conditions. Drugs for these diseases often entailed higher costs, streamlined reviews, and added patent safeguards.

In another part of the globe, the European Medicines Agency recommended 93 new drugs in 2015, a rise from 82 in 2014.

Soaring Prescription Drug Prices

Issues rocking the industry include the rising cost of prescription drugs, which even prompted congressional inquiry and served as a presidential campaign issue in 2015. The FDA, while urged that it should, is not allowed to factor in drug costs during approvals.

Democratic presidential candidates Hillary Clinton and Bernie Sanders, for instance, have plotted plans to help curb drug prices.

Orkambi, a cystic fibrosis medication from Vertex Pharmaceuticals, emerged as one of the costliest ones, selling for $259,000 for a year’s worth. It targets lung functioning in patients of the condition resulting in sticky mucus accumulation in the lungs and other organs.

Pfizer drug Ibrance from breast cancer cost $118,200 a year, a price tag characteristic of new cancer drugs. Meds for more prevalent conditions also commanded high prices, including hepatitis C pill Daklinza at $63,000 for a 12-week therapy.

Drug R&D Challenges

Drugmakers, according to industry experts, are becoming pickier at choosing which drugs to develop in their labs. At present, a mere one in 13 drugs in early phases make it to the market. From 2007 to 2011, a mere one in 19 early-phase drugs reached the market, said Tim Anderson of Bernstein.

"These improvements hopefully reflect the pay-off from the industry's conscious decade-long efforts to 'turn around' R&D," reported Anderson to investors last year.

Anderson added that due to the mounting complexity of trials and health insurers’ increased demand for information, the average drug development time rose to about 14 years today, compared to around 11 years in the late ‘90s.

Deloitte, in a separate report, noted that leading pharmaceuticals could take their cue from the R&D of mid-sized companies, who likely target a specific disease group. These mid-sized firms tend to incur lower R&D costs and higher individual product sales.

Forecasts And Projections

Industry-wide profitability could be hounded by Clinton presidency, provided she pledged to control drug prices.

The tight competition between new drugs and a growing lineup of cheap generics will continue, while modern cancer treatments can be priced as over $10,000 a month and continue to place a heavy burden upon patients, insurers, and the U.S. government.

Analysts added, however, that cancer therapies could veer toward enhancing the immune system. Drug research in autoimmune diseases, too, could significantly improve.

Just recently, the FDA approved a new cancer treatment that could replace chemotherapy with a quick injection and can be a landmark success in managing the disease.

World’s largest cancer drugmaker, Roche, has its cancer immunotherapeutic drug atezolizumab for potential fast-track approval this year. New products in the FDA approval pipeline include those for hepatitis C, rheumatoid arthritis, and psoriasis.

Amid difficulties, experts like IMS Health predicted that 225 new drugs will be green-lighted from 2016 to 2020 worldwide.

Photo: Melanie Tata | Flickr

ⓒ 2021 All rights reserved. Do not reproduce without permission.