FDA report: 35 new drugs approved in past year
SILVER SPRING, Md. — The Food and Drug Administration has approved 35 new drugs over the past 12 months, the agency said Thursday.
In a new report titled "FY 2011 Innovative Drug Approvals," the agency said many of the drugs were important advances for patents, including two new drugs for hepatitis C, one for late-stage prostate cancer, the first new drug for Hodgkin’s lymphoma in 30 years and the first new drug for lupus in 50 years. Others included one drug for melanoma and another for lung cancer that were approved with diagnostic tests — approvals that the FDA said were breakthroughs in personalized medicine. Ten of the new drugs are for rare, "orphan" disease states, such as hereditary angioedema.
"Thirty-five major drug approvals in one year represents a very strong performance, both by industry and by the FDA, and we continue to use every resource possible to get new treatments to patients," FDA commissioner Margaret Hamburg said. "We are committed to working with the industry to promote the science and innovation it takes to produce breakthrough treatments and to ensure that our nation is fully equipped to address the public health challenges of the 21st century."
The FDA said the report shows faster approval times in the United States compared with similar agencies in other countries: Of the 35 new drugs, 24 received approval in the United States before any other country. Part of the reason for this, FDA Center for Drug Evaluation and Research director Janet Woodcock said, was the Prescription Drug User Fee Act, passed by Congress in 1992.
"Before the PDUFA program, American patients waited for new drugs long after they were available elsewhere," Woodcock said. "As a result of the user fee program, new drugs are rapidly available to patients in the United States while maintaining our high standards for safety and efficacy."
Click here to read the FDA’s report.
FDA approves generic version of Merck’s Elestat ophthalmic solution
ALLEGAN, Mich. — The Food and Drug Administration has approved a drug made by Perrigo and PharmaForce/Luitpold Pharmaceuticals for treating eye allergies, Perrigo said.
The FDA approved epinastine hydrochloride ophthalmic solution in the 0.05% strength. The drug is a generic version of Merck’s Elestat, used to treat ocular itching related to allergic conjunctivitis.
Annual sales for the branded version before the appearance of generics on the market were $30 million, according to Wolters Kluwer.
NCPA CEO issues statement on Express Scripts-Medco merger at pharmacy coalition press conference
WASHINGTON — At a press conference organized by the Preserve Community Pharmacy Access NOW! coalition at the Capitol on Thursday morning, the National Community Pharmacists Association’s CEO Douglas Hoey issued a statement regarding the proposed merger of pharmacy benefit managers Express Scripts and Medco Health Solutions, saying the deal could mean "more wasteful mail-order spending and higher price spikes for specialty drugs."
"Quite simply, the windfall profits of major PBMs have soared and everyone else has been paying the price," Hoey said. "The marriage of Express Scripts and Medco would give one corporation control of nearly 60% of the mail-order pharmacy market and 52% of the specialty pharmacy market. It could mean more wasteful mail-order spending and higher price spikes for specialty drugs. The already limited pharmacy management options for the largest health plans, including the federal government, will grow further captive to the major PBMs.
"Currently 42 out of the Fortune 50 largest U.S. employers use the ‘Big Three’ — Express Scripts, Medco or CVS Caremark. It is safe to say that if the merger is green-lighted, the remaining two companies would face little, if any, resistance to raising costs, reducing choice and otherwise putting their own interests ahead of those of employers, patients and others," Hoey said.
Hoey also added that the "unchecked, virtually unregulated growth" among PBMs should prompt Congress to pass legislation — particularly, the Pharmacy Competition and Consumer Choice Act of 2011 (S. 1058/ H.R. 1971), and the Preserving Our Hometown Independent Pharmacies Act (H.R. 1946) — to boost patients’ choice of pharmacy.
On hand at the PCPA NOW! press conference were Reps. Joe Courtney, D-Conn.; Thomas Marino, R-Pa.; and Eva Clayton (retired), who also serves as PCPA NOW! chairwoman; Dennis Archer, PCPAN chief legal counsel; and Mike Brandt, owner of Globe Drug and Medical Equipment.