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New Report Shows Dangerous Gap in Drug Safety Efforts; Senator Asks FDA to Tighten Oversight on PHARMA Outsourcing
For several years, Senator Sherrod Brown has been raising the flag on potential quality problems posed by outsourced manufacturing.
He is now calling on the FDA to look more closely at outsourcing APIs for drugs made at home.
A new report has found that more than 80% of APIs are made abroad, mostly in plants rarely inspected by the FDA.
Outsourcing pharmaceutical ingredients results in outsourcing drug safety standards.
Brown said “It’s simply unacceptable to allow drug companies to skirt existing regulations by importing ingredients from countries with lax safety standards."
Brown sent a letter to FDA Commissioner Margaret Hamburg citing all these things and posing some additional questions, including, “Have FDA inspectors ever denied access to foreign API plants and if so, could FDA bar the products from those plants?”
The letter also hints at potential new rules, including the feasibility of charging fees when PHARMA companies move operations overseas to help pay for FDA inspections of those plants.
Senator Brown has previously introduced legislation to mandate a country-of-origin labeling requirement for pharmaceuticals.
www.fiercepharma.com/press_releases/wake-new-report-showing-dangerous-gap..
CE Influences Physician Prescribing, Followed by Dinner Meetings and E-mail
A new survey reveals that conferences and CME show the highest rates of influence on physicians to increase their prescribing of selected products, with over 50% of respondents predicting higher intent.
Face-to-face sales visits registered about 40%, dinner meetings registered somewhere between 40% and 50%, and e-mail between 20% and 30%.
One reason given for why CME and conferences outscored the other two channels-detailing and mailings-is because doctors tend to be looking for more authoritative sources of information.
The survey included 2,455 physicians and others.
www.mmm-online.com/cme-exerts-highest-influence-on-docs-intent-to-rx-survey..
Drug R&D Spending Fell 3% to $68 Billion in 2010 from $70 Billion in 2009 and 2008 and May be Heading Lower
Pharmaceutical research and development has experienced the first-ever decline.
It may become a trend that continues as Pfizer, and others, do more downsizing.
The overall expenditure on discovering and developing new medicines amounted to an estimated $68 billion last year, down nearly 3 percent on the $70 billion spent in both 2008 and 2009.
The fall reflects a growing disillusionment with poor returns on pharmaceutical R&D.
Disappointing research productivity is arguably the biggest single factor behind the declining valuations of the sector over the past decade.
In the past, R&D laboratories have been largely immune to cost cutting; however, that has changed, and in recent months the pace of cutbacks has increased.
Pfizer has taken the most dramatic steps with plans to slash around a quarter of its R&D budget over the next two years; other companies have also made smaller cuts.
Decreasing research budgets represents a major change for an industry that has invested billions of dollars into the hunt for new drugs, often with little to show for it.
www.reuters.com/article/2011/06/26/pharmaceuticals-rd-idUSL6E7HO1BL20110626
Many Drugs in Short Supply at Hospitals, Pharmacies
“Every month we review what’s not available to us,” said Dr. Pamela Lipsett, a professor of surgery at Hopkins.
“We get one [drug] back and lose another.
And some diseases have only one drug.
It’s very frightening.”
This may leave patients with less effective or more costly substitutes.
The FDA says that shortages of prescription drugs have tripled during the last six years to a record high.
There were 61 drug product shortages in 2005, 178 in 2010, and even more in 2011.
Many factors are blamed, including natural disasters, raw material shortages, changes in hospital and pharmacy contracts, changes to FDA protocols and discontinued medicines.
Also, industry consolidation is a factor, as are makers who discontinue less profitable generic drugs or whose plants fail safety inspections, especially involving sterility.
U.S. hospitals have spent at least $200 million, or 11 percent, more a year on substitutes, according to a study of 228 hospitals, retail pharmacies, and other care facilities.
This estimate doesn’t include added labor for managing shortages or ensuring safety.
Nearly 90 percent of the hospitals reported a drug shortage in the second half of 2010 that may have caused a patient-safety issue, resulted in procedure's delay or cancellation, required expensive substitutes, or resulted in a pharmacist compounding a drug.
www.baltimoresun.com/health/bs-hs-drug-shortage-20110625,0,324165.story
Medi-Cal Cuts Sought as Stimulus Funds Run Out
California Medi-Cal funding of billions of federal stimulus dollars will run out Friday.
Simultaneously, California is trying to get approval for a series of cuts to the health program.
Of the $90 billion the federal administration injected into the Medicaid program for the U.S., California received about $12.4 billion (almost 14%).
The extra help meant the federal government matched California at 62 cents on the dollar instead of 50 cents.
Now, for the first time, patients will have to pay $5 to see a doctor and $3 for prescription drugs.
The number of covered doctor’s office visits will be capped at seven per year unless deemed medically necessary.
Doctors, hospitals, health plans, and other providers will see a 10 percent reduction in payments for treatment.
www.sfgate.com/cgi-bin/article.cgi?f=/c/a/2011/06/29/MNAE1K4G89.DTL
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