PhRMA voices concern over higher copays under ACA | FDA moves to open up data on adverse events | Hospitals spend $230M for alternate sources of scarce meds, survey finds
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February 28, 2014
PhRMA Daily News

Top Story
PhRMA voices concern over higher copays under ACA
A HealthPocket study found that people who use multiple prescription drugs will be affected most by higher coinsurance fees and copayments under the Affordable Care Act. "In chronic conditions like heart [disease] or diabetes, where there are medications to manage conditions, we're really concerned that all of the progress that's been made in the last 10 years could be lost," said PhRMA Executive Vice President of Public Affairs Josie Martin. "People are going to have trouble adhering to their medications if they are out of reach financially." Medill Reports (Northwestern University) (2/27)
FDA moves to open up data on adverse events
The FDA is planning to give the public greater access to data on reports of adverse events involving prescription drugs through the openFDA project. Giving doctors and patients more information is a good thing, but it's important that context be provided, PhRMA Senior Counsel Jeff Francer said. "We wouldn't want patients to be scared by just receiving adverse event information in absence of a more full discussion of both the benefits and the risks of a medicine," he said. Bloomberg Businessweek (2/27)
Access and Costs
Hospitals spend $230M for alternate sources of scarce meds, survey finds
Obtaining drugs from alternate sources to cope with shortages of hundreds of medications is costing 5,000 U.S. hospitals an estimated $230 million annually, according to a survey by the hospital group Premier. The estimate does not cover costs for overtime or additional workers as staff seek out supplies. Canadian Press (2/27)
Other News
FDA/Regulatory Affairs
FDA regulation of shoddy generics is not enough, docs tell Congress
The FDA has not tracked the efficacy of generic drugs that constitute 80% of medications on the U.S. market, researchers and doctors said during a briefing in Washington attended by 50 congressional staffers and federal officials. Brigham & Women's Hospital researcher Preston Mason said some generic heart treatments produced in India don't work as intended, possibly because certain companies are taking shortcuts to reduce costs. Cleveland Clinic cardiologist Harry Lever said that in his experience patients who didn't respond to generics manufactured overseas have fared better after they are switched to branded drugs or to generics made in the U.S. Bloomberg (2/26)
Decision in Halliburton class-action case could affect pharma
The Supreme Court will hear arguments in a Halliburton appeal that challenges the legal doctrine allowing class actions in securities fraud cases. The outcome would have an effect on pending cases involving Pfizer and Amgen, experts say. Bloomberg (2/27)
Medical Progress & R&D
Open up more clinical trials to pregnant women
Data is needed on the effectiveness and safety of new prescription drugs during pregnancy, but for decades regulatory agencies like the FDA have endorsed the exclusion of pregnant women from clinical studies, writes ethicist Sean Philpott. Current guidelines on pregnant women's inclusion in clinical studies should be reassessed, he writes. It is puzzling that "natural experiments" are relied upon when the needed safety and efficacy data could be collected by performing studies on willing and informed participants, he writes. WAMC-AM/WAMC-FM (Albany, N.Y.) (2/27)
Comedic actor brings levity, gravity to Alzheimer's hearing
Comedic actor Seth Rogen was among the doctors, researchers and patients testifying before a Senate Appropriations subcommittee hearing on Alzheimer's disease. Rogen founded the foundation Hilarity for Charity after watching his mother-in-law struggle with Alzheimer's disease in her 50s and 60s. Rogen agreed that young people should be encouraged to pursue careers in science and also suggested that Congress provide more reliable funding for research. Daily News (New York) (2/26), National Journal (2/27), ABC News (2/26)
20-something seeks cystic fibrosis cure before it's too late
Emily's Entourage, a foundation founded three years ago by 29-year-old Emily Kramer-Golinkoff, has raised about $630,000 for cystic fibrosis research through an annual event and an aggressive social media campaign. Kramer-Golinkoff has a rare form of cystic fibrosis and is seeking a cure through the foundation's efforts before the disease kills her. Similar family-run foundations have sprung up over the last five years, as patients and their families work to personalize and accelerate research, said Cecilia Arradaza, FasterCures' managing director for community and policy. The Philadelphia Inquirer (2/26)
International Issues & Intellectual Property
FDA, EMA find no evidence of link between GLP-1 drugs, pancreas problems
The FDA and the European Medicines Agency reported that reviews of animal and human studies did not indicate a link between diabetes drugs known as GLP-1 medicines -- such as Janumet, Victoza and Byetta -- and an increased risk of pancreas problems or pancreatic cancer. However, the agencies have not reached a final conclusion on the medications' effects on the pancreas and will continue to assess their safety profiles, agency scientists wrote in the New England Journal of Medicine. The Boston Globe (tiered subscription model)/The Associated Press (2/26)
Additional Issues
Opioid prescribing rate down about 5%
Health care providers wrote about 230 million prescriptions for opioid drugs in 2013, down about 5% from 241 million in 2012, but some experts said the heightened focus on opioids should have yielded a greater decline. Though opioid prescriptions were down, the number of prescriptions rose for tranquilizers and weaker opioids, according to IMS Health. The Obama administration has called for tighter prescribing controls and greater use of prescription drug monitoring programs, but their use is spotty even in states with mandatory programs. MedPage Today (free registration)/Milwaukee Journal Sentinel (2/26)
Almost 20% of ACS patients don't receive recommended treatment
An analysis of data on 80,241 patients with acute coronary syndrome who participated in a heart disease program from January 2005 to December 2009 showed that almost 1 in 5 eligible patients did not receive angiotensin-converting enzyme inhibitors or angiotensin receptor blockers after hospital discharge despite recommendations from the American College of Cardiology and American Heart Association. The prescription rate for the drugs rose from 76.7% to 84.6% over the study period. The findings appear in the journal Circulation: Cardiovascular Quality and Outcomes. Healio (free registration)/Cardiology Today (2/26), News (2/26)
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-- Ray Kroc,
American businessman
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