FDA touts uptick in new drug approvals

Matthew Perrone, AP Health Writer

WASHINGTON (AP) -- The Food and Drug Administration is highlighting an uptick in new drug approvals after a decade-long downturn in the number of innovative medications approved by the agency.

The agency cleared 35 first-of-a-kind prescription drugs in the last twelve months, the second-highest annual number in the past decade, according to a report issued Thursday. Only the 37 drugs approved in the agency's 2009 fiscal year exceeded the number for fiscal 2011.

On a call with reporters, FDA officials touted the higher number of first-in-class drugs while acknowledging the agency can only approve drugs submitted by the pharmaceutical industry.

"We're not taking credit for these innovative medicines, but we are trying to demonstrate that by working closely with industry and the broader biomedical research community, we can produce the kind of innovative medicines the American public needs," said FDA Commissioner Dr. Margaret Hamburg.

The director for FDA's drug center said the higher number of approvals was not the result of an uptick in applications, though the agency's report did not provide total drug applications submitted to the agency. Dr. Janet Woodcock suggested the number of drugs submitted to the FDA has held steady, while the level of innovation has improved.

"Typically we would see a lot of `follow-on' or `me-too' products, whereas this year we're just seeing a lot of innovation," said Woodcock.

The uptick in approvals comes after a decade in which pharmaceutical research and development budgets ballooned to record highs, while yielding fewer products than in earlier decades.

Industry spending on research rose to $50 billion last year, nearly doubling from 2000. FDA drug approvals touched an all-time high of 53 in 1996, the mid-point of a decade considered the boom years for U.S. pharmaceutical industry. The number of first-of-a-kind drugs approved has declined since then, with the annual tally averaging 21 over the last five calendar years, according to FDA figures.

The FDA is highlighting its drug approval program even as its medical device section has come under attack from industry executives and lawmakers on Capitol Hill. The Republican-controlled House of Representatives has held multiple hearings this year to air concerns from medical device makers that FDA regulation is slowing down product launches, and forcing some smaller companies out of business.

Faced with criticism from the business community and Capitol Hill, the FDA is rolling out a publicity campaign focused on innovation, or ways the agency is helping to approve new medical treatments.

The FDA said half of the drugs approved in the last year received a "priority review" of six months, compared with the regular 10 month review. The FDA grants priority review when a drug fills an unmet medical need or represents a significant improvement to treatments already on the market.

The agency's emphasis on speedy clearance marks a break from earlier in the decade, when drug-safety scandals like Merck & Co. Inc.'s painkiller Vioxx led to criticism that FDA was clearing drugs too quickly.

The agency report issued Thursday highlights more than a dozen innovative drugs approved in the past year including:

-- the first new drug for lupus in 50 years

-- two new drugs for hepatitis C that significantly raise the cure rate for the disease

-- seven new drugs for cancer

The newer therapies tend to target smaller groups of patients and often come with six-figure price tags. Four of the seven cancer drugs approved in the last year cost around $100,000 or more for a year's supply, including: Pfizer Inc.'s lung cancer drug Xalkori, Bristol-Myers Squibb Co.'s and Roche's melanoma drugs Yervoy and Zelboraf, respectively, and Seattle Genetics Inc.'s lymphoma drug Adcetris.