Industry News
Thailand to Keep Generic Drugs Scheme: Minister
Thailand’s new health minister said today he would keep the country’s controversial generic drugs program but stopped short of saying whether the new government would expand the scheme. The army-backed government in Thailand already overrode patents for popular heart drug Plavix and two key AIDS medicines — Kaletra and Efavirenz — and was planning to expand the program to include cancer drugs.
Source: Pharmalive.com
More Americans Are Using More Prescription Drugs
ST. LOUIS–(BUSINESS WIRE)- More U.S. adults are taking prescription drugs than ever before, fueling $12 billion in additional spending during 2006 alone. The number of people with at least one prescription increased from 67% to 74% between 2000 and 2006, according to a new Geographic Variation in Prescription Utilization study by pharmacy benefit manager Express Scripts. The number of prescriptions per person rose to 14.3 from 10.8 in 2000 - a 32 percent jump.
The study correlates the climb in increased spending for antidiabetic and antihypertensive prescription drugs with rising obesity rates. The top five states (West Virginia, Kentucky, Alabama, Mississippi, Louisiana and Arkansas) in the study’s ranking of per capita spending increases for drug classes linked to obesity were also the states with the top five obesity rates, according to the U.S. Centers for Disease Control and Prevention.
“The $12 billion in additional spending in 2006 would have been much greater had the nation not increased its use of lower cost generic drugs from 40% to 58% over the intervening years,” explains Emily Cox, senior director of research for Express Scripts. “In fact, greater use of generic drugs still has significant potential for managing prescription drug costs. The key will be using an advanced understanding of the consumer to get more people to choose generics.”
Conducted within the commercially insured market, the study evaluated overall prescription drug use, analyzing commonly prescribed therapy classes to highlight national and state-by-state trends. Medications from four of the seven therapy classes evaluated are frequently used to treat conditions associated with obesity and related chronic conditions such as high cholesterol, diabetes and high blood pressure. These four therapy classes include antihyperlipidemics, antidiabetics, antihypertensives and gastrointestinal (GI) medications. Also studied were analgesics/anti-inflammatories, antidepressants and estrogen.
The state-by-state analysis found that overall usage and rates of increase varied significantly across geographic regions with the South experiencing the highest utilization and greatest increase in use.
Source: BusinessWire
Drug Ads to Get More FDA Scrutiny
By Julie Schmit, USA TODAY
The Food and Drug Administration’s current budget for reviewing consumer drug advertisements is larger than in the previous five years combined.
But whether that level of funding will be sustained and continue to come from taxpayers - or will be raised from drugmakers through new user fees - is likely to be battled out in Congress as it addresses future FDA funding.
The FDA received $6.1 million for the current fiscal year to check the fairness and accuracy of consumer drug ads. That’s up from $2.2 million the previous year and $1 million the year before.
The FDA says it plans to hire more people so it can review more ads. It has 13 workers devoted to policing direct-to-consumer ad materials. Six are primary reviewers. Last year, the FDA received 12,616 drug ad materials directed to consumers.
The FDA has long been so overwhelmed by drug industry ad materials that only a “small portion” is reviewed, the Government Accountability Office said in a 2006 report. The FDA often didn’t declare consumer ads false or misleading until after ad campaigns were over, the GAO said.
The boost in 2008 funds came after Congress approved user fees for drug ad reviews, but the program wasn’t launched amid funding issues and opposition from some lawmakers, including Rep. Rosa DeLauro, D-Conn., who chairs a subcommittee overseeing FDA funds.
President Bush seeks to resurrect the fees. The proposed 2009 budget he sent to Congress this month calls for $14 million from fees to fund 27 FDA positions devoted to the consumer-ad-review program. In exchange, the FDA would review TV drug ads within 45 days of getting them from drugmakers - which is faster than many reviews occur now - and before the ads are seen by millions of viewers.
The drugmakers’ trade association, Pharmaceutical Research and Manufacturers of America, supports user fees. Timely FDA review would help drugmakers meet marketing goals and lessen the risk of running ads later cited by the FDA for false or misleading content.
The FDA can recommend changes in an ad it considers misleading. Drugmakers can be fined if they run ads without changes.
The FDA already collects user fees for reviews of new human and animal drugs and medical devices. In Bush’s proposed budget, a quarter of the FDA’s funds would come from fees paid by industries the FDA regulates.
DeLauro is likely to continue to be a staunch opponent. “I believe Congress should provide a direct appropriation in order to minimize industry influence in the FDA,” she says.
Source: USA Today
Paying Patients Test British Health Care System
By SARAH LYALL
LONDON - Created 60 years ago as a cornerstone of the British welfare state, the National Health Service is devoted to the principle of free medical care for everyone. But recently it has been wrestling with a problem its founders never anticipated: how to handle patients with complex illnesses who want to pay for parts of their treatment while receiving the rest free from the health service.
Although the government is reluctant to discuss the issue, hopscotching back and forth between private and public care has long been standard here for those who can afford it. But a few recent cases have exposed fundamental contradictions between policy and practice in the system, and tested its founding philosophy to its very limits.
One such case was Debbie Hirst’s. Her breast cancer had metastasized, and the health service would not provide her with Avastin, a drug that is widely used in the United States and Europe to keep such cancers at bay. So, with her oncologist’s support, she decided last year to try to pay the $120,000 cost herself, while continuing with the rest of her publicly financed treatment.
By December, she had raised $20,000 and was preparing to sell her house to raise more. But then the government, which had tacitly allowed such arrangements before, put its foot down. Mrs. Hirst heard the news from her doctor.
“He looked at me and said: ‘I’m so sorry, Debbie. I’ve had my wrists slapped from the people upstairs, and I can no longer offer you that service,’ ” Mrs. Hirst said in an interview.
“I said, ‘Where does that leave me?’ He said, ‘If you pay for Avastin, you’ll have to pay for everything’ ” - in other words, for all her cancer treatment, far more than she could afford.
Officials said that allowing Mrs. Hirst and others like her to pay for extra drugs to supplement government care would violate the philosophy of the health service by giving richer patients an unfair advantage over poorer ones.
Patients “cannot, in one episode of treatment, be treated on the N.H.S. and then allowed, as part of the same episode and the same treatment, to pay money for more drugs,” the health secretary, Alan Johnson, told Parliament.
“That way lies the end of the founding principles of the N.H.S.,” Mr. Johnson said.
Read the full report from the New york Times
The Associated Press
WASHINGTON — The Food and Drug Administration announced plans Friday to place regulators in China, pending approval from the Chinese government.
The agency said the State Department had approved a plan to establish eight full-time, permanent FDA positions at U.S. diplomatic posts in China. The FDA also plans to hire five Chinese employees to work with the FDA at the U.S. Embassy in Beijing and the U.S. consulates in Shanghai and Guangzhou.
“Our efforts to fill permanent FDA positions in China are a significant step toward ensuring access to safe food, drugs and medical devices in the global market,” said Murray M. Lumpkin, the FDA’s deputy commissioner for international and special programs.
Over the past year, U.S. regulators have recalled a number of contaminated products, including toothpaste, pet food and the blood thinner heparin, made in China.
FDA Commissioner Andrew von Eschenbach said last month that the FDA must make major changes to keep up with complex global markets that mean more and more U.S. food and medicine is produced abroad.
© 2008 The Associated Press
Read the full report from the Associated Press