FDA, EMA program would allow joint inspections of generic drug manufacturing facilities
SILVER SPRING, Md. — The Food and Drug Administration and the European Medicines Agency will share data about studies meant to show whether generic drugs are equivalent to their branded counterparts, under a joint program announced Wednesday.
The FDA and the EMA, which regulates drugs in the European Union, said the effort would provide a way to conduct joint inspections of drug makers’ factories and other facilities for generic drug approval applications submitted to both agencies. Under U.S. and E.U. regulations, studies submitted for generic drug applications must demonstrate scientifically that they are "bioequivalent," meaning they’re as safe and effective as the branded drugs they’re based upon. The FDA and E.U. regulatory authorities inspect drug makers’ manufacturing facilities to ensure the data they submit are reliable.
"Our continued collaboration with the EMA and the E.U. enhances our ability to leverage inspection resources and helps us meet the challenges of increased globalization in drug development," FDA Center for Drug Evaluation and REsearch director Janet Woodcock said. "By streamlining the inspection process for generic drug applications, we will help consumers gain access to safe and effective generic drugs."
The FDA, EMA and individual E.U. member states France, Germany, Italy, the Netherlands and the United Kingdom will all take part in the initiative, the FDA said.
Most savings from generics came from retailers during last decade, report finds
WASHINGTON — The U.S. healthcare system saved $217 billion in 2012 thanks to the use of generic drugs, according to a new report by a generic drug industry trade group.
The report, compiled by IMS Health on behalf of the Generic Pharmaceutical Association, found that since 2003, the healthcare system has saved $1.2 trillion. This year’s report was also the first to break out savings by payer type at the retail level, finding in 2012 alone, $171 billion in savings came from retail, while retail savings over the past decade were $931 billion, or 76% of the total. Total generic savings in 2011 were $188 billion, and the annual rate of increase in savings has been about 17% per year since 2007.
Meanwhile, out-of-pocket cash payers have saved $78 billion over the past decade, most of them uninsured and poor customers, and Medicaid beneficiaries who got prescriptions from retailers accounted for $96 billion in savings over the decade. Medicare Part D and other federal programs accounted for $301 billion, while seniors enrolled in Medicare Part D themselves since the program started in 2006 accounted for $180 billion.
"From policymakers to patients, any efforts to curtail health spending must capitalize on the savings from safe, affordable generic medicines," GPhA president and CEO Ralph Neas said. "In a time when cutting costs is everyone’s priority, generics continue to put more treatments within reach for so many people. Embracing policy that encourages access to generic medicines goes hand-in-hand with savings."
In total, Americans spent about $325.8 billion on prescription drugs in 2012, according to the report, a figure that could reach as high as $450 billion by 2017 if enrollment in the Patient Protection and Affordable Care Act insurance exchanges reaches capacity and if branded drug prices continue increasing above the inflation rate. "This level of spending would be unsustainable if not for the savings generated by the use of generic drugs," the report read.
More than half of the total savings come from new generics, defines as those introduced in the past 10 years, with $157 billion of the total for 2012, or 72%, coming from the newer generics, compared with $123 of the total in 2011, or 65%.
Mylan Specialty announces winners of anaphylaxis awareness campaign
PITTSBURGH — Four school districts have won a competition sponsored by Mylan to raise awareness about dangerous allergic reactions, the company said Wednesday.
Mylan, whose Mylan Specialty division makes the EpiPen injector pen for severe allergic reactions, known as anaphylaxis, announced the winners of the Raise Your Hand for Anaphylaxis Awareness competition, for which it hired actress Julie Bowen as a celebrity spokeswoman.
The winning school districts are the Cheektowaga-Sloan Union Free School District, Cheektowaga, N.Y.; the Oxford Township School District, Oxford, N.Y.; the Utica Community Schools, Sterling Heights, Mich.; and the Ossining Union Free School District, Ossining, N.Y.
The competition called for local communities to educate others in the school environment to recognize a life-threatening allergic reaction and be prepared to respond if one occurs. It included more than 830 school districts in all 50 states, calling on students to virtually "raise hands" and express awareness of anaphylaxis. In total, the campaign received nearly 150,000 responses in four months.
Each of the winning school districts will be awarded a $15,000 educational grant, which they are encouraged to use to fund programs about life-threatening allergies, such as training staff, inviting speakers and implementing hand-washing stations throughout the school.