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given the deferential, perfunctory manner of drug approval at the FDA, it's arguable the GOP did us all a favor:
http://www.forbes.com/sites/davidmar...-at-the-fda/3/
Generic Drugs Hit Backlog At FDA
No Plans to Expand Review Capabilities
By Marc Kaufman
Washington Post Staff Writer
Saturday, February 4, 2006; A01
At a time when low-cost generic drugs are being embraced as among the few ways to slow skyrocketing health care costs, the Food and Drug Administration has a backlog of more than 800 applications to bring new generic products to the market -- an all-time high.
As a result, experts say, fewer generic drugs will be available to consumers in the years ahead than the industry is ready and able to provide.
The FDA, however, has told Congress that the office that reviews new generics needs no additional money, and the agency has no plans to hire more reviewers.
( of course not, generics reduce the profits of Repug campaign donors )
"We are very aware that many, many people are waiting for more generics to be approved and that there is frustration about the backlog," said Gary Buehler, director of the agency's Office of Generic Drugs.
He said he expects a record number of applications this year -- and an even larger backlog -- because "we don't believe we'll be getting any staff increases in 2006." Buehler said his office received an all-time monthly high of 129 applications in December.
The Bush administration has strongly advocated generics as a way to hold down health care costs, and the director of the Centers for Medicare and Medicaid Services, Mark B. McClellan, said in an interview this week that an ever-growing number of generics is essential to controlling the cost to the government and seniors of the new Medicare prescription drug program.
( BUT! Another $70B for a bull war. dubya is all bull and no action, no policies )
In a recent federal report on health care costs, one of the few bright spots was a slowdown in the rate of prescription drug spending that was credited largely to the growing use of generics, which now account for more than half of all prescriptions."This huge backlog of generic applications is just unacceptable," said Rep. Henry A. Waxman (D-Calif.), one of the sponsors of the law that made generics more easily available two decades ago. "This is the time for the FDA to be ramping up its generic reviews, not to be falling so badly behind."
Last year, the generics office approved more than 450 applications, 23 fewer than the year before. The office took an average of 20.5 months to review each application, compared with 19.9 months in 1999, although by statute the agency is obliged to do the job within six months.
The FDA's Buehler said the agency gives priority to "first generic" applications, for drugs just losing patent protection, but do ents show that the backlog for all generics is double what it was just three years ago.
As the backlog of generic applications has soared, the number of applications for new or reformulated drugs and biologics submitted by brand-name companies has remained consistently smaller than predicted.
But while the Office of Generic Drugs had about 200 employees to process almost 800 new applications last year, the offices that review new drugs had more than 2,500 employees for about 150 applications in 2004.
( FDA getting new proprietary drugs to the market benefits the the Repub campaign donor profits, while FDA keeping generics off the market protects and extends profits for proprietary drugs )
The generics office's budget was about $26 million last year, a fraction of the more than $400 million spent to evaluate and monitor new drugs and biologics, according to FDA do ents. In response to questions from Congress, the agency said the generics program would have to make cuts in 2006 to offset pay raises.
( DoD is getting $425B next year. Repug Iraq war, $70/year, $6B/month )
"We have a kind of crazy situation now where the FDA's generic reviews -- which are supposed to be quicker because they're less complicated -- on average take longer than the new drug reviews," said Kathleen Jaeger, president of the Generic Pharmaceutical Association.
"The flood of applications is coming in generics, but the review resources mostly go to new drugs."
A generic drug, which comes on the market after another drug's patent expires and must have the same active ingredients as the drug it mimics, usually costs 60 to 90 percent less than the brand-name version. The cost drops the most with the first generic alternative to a brand-name drug, and it falls more as each new compe or reaches the market.
Consumer acceptance of generics has increased markedly in recent years. Drug experts say the tidal wave of demand reflects the high price of branded products, the large number blockbuster drugs going off patent, a big push by insurers and the government to encourage generic usage, and an influx of cheap medicines made by Asian manufacturers. These companies are filing applications to market drugs just coming off patent as well as lesser-used older medications that do not have generic compe ion.
Generic drugs now account for about 12 percent of the nation's $250 billion a year in drug spending and more than 53 percent of prescriptions filled. IMS Health, a company that tracks the industry, predicts that the percentage will exceed 65 percent within four years as several blockbuster drugs go off patent. Express Scripts, which manages pharmacy benefits for many insurers, estimates that the figure could be 70 to 75 percent by 2010.
Drug experts say more widespread use of generics could save billions.
( but the Repugs run the country to enrich the rich + corps, while screwing everybody else )
The Express Scripts study estimated that wider generic use could have saved $20 billion in 2004 alone. But because many generic drugs are antibiotics or other drugs that treat short-term conditions -- rather than the chronic problems treated by brand-name cholesterol, blood-pressure and antidepressant drugs -- only 37 percent of drugs dispensed, as opposed to prescriptions, are generic, according to IMS Health.
The FDA backlog is expected to balloon in the next few years. An unprecedented $60 billion to $70 billion a year worth of brand-name drugs -- such as Zocor, Zoloft, Pravachol and Ambien -- will come off patent in the United States over the next four years, creating opportunities for spirited generic compe ion and greatly reduced prices.
"It's pretty simple -- the more generics we have, and the more quickly we get them, the more savings for consumers," said Steve Miller, author of the Express Scripts study.
Mark Merritt, president of the Pharmaceutical Care Management Association, which represents pharmacy benefit managers, said 90 percent of the time doctors and patients agree to switch to a newly approved generic by the next refill.
But without an increase in staffing at the Office of Generic Drugs, advocates of generics say, the public will get those savings more slowly, and sometimes not at all.
The view within the FDA appears to be quite different. In testimony before Congress last summer, then-FDA Commissioner Lester M. Crawford said the agency was approving on average one generic drug per day, calling that a sign that "the system seems to be working" and that "we are meeting our deadlines." He said there was no need for additional staff in the generics office.
( another Repub political operative botches his job:
FDA Commissioner Steps Down After Rocky Two-Month Tenure
By Marc Kaufman
Washington Post Staff Writer
Saturday, September 24, 2005; A07
Food and Drug Administration Commissioner Lester M. Crawford announced his resignation yesterday, just two months after he was confirmed for the job. His e-mail notice to the FDA staff gave no reason for his surprise decision to step down.
Sources familiar with his departure said Crawford was asked to resign, though it was unclear why. Crawford has had a stormy tenure at the agency, which has been beset by criticism from both the left and the right over its actions regarding drug safety and emergency contraception.
He was also accused before his confirmation of having an improper relationship with a female colleague -- a charge that independent investigators said both parties denied. The final report did note, however, significant discrepancies between Crawford's testimony and that of others in the commissioner's office. )
Some at the agency and in the industry say the answer is to have generic-drug makers do what brand-name makers did in the early 1990s -- pay "user fees" to finance new hires by the FDA. Today, user fees support about half the FDA staff that reviews new drug applications.But the generic drug industry includes hundreds of small firms, and its leaders say they cannot reach consensus on whether to accept user fees.
Others argue that since the low cost of generics has broad benefits for the public, Congress should be willing to pay for added staffing. That the administration has not asked for more money, some say, indicates that it favors the big drug companies.
( duh! )
"The branded industry has to be delighted by this backlog," said Jake Hansen, vice president for government affairs for Barr Laboratories Inc., a maker of generic drugs. "If they can't stop compe ion in the courts, stopping it as applications go through the regulatory process is just as effective. For consumers, to flatline or cut funding makes absolutely no sense."
Sharon Levine, who oversees drug utilization for the Kaiser Permanente health plan in Northern California, said it is essential for the FDA to speed the approval of new generics.
"The agency has done a good job of getting a wide range of generics onto the market so far, so it's worrisome if that flow might be slowing down," she said.
© 2006 The Washington Post Company
given the deferential, perfunctory manner of drug approval at the FDA, it's arguable the GOP did us all a favor:
http://www.forbes.com/sites/davidmar...-at-the-fda/3/
Approved drugs, including prescription and OTC, kill 10Ks every year.
How many do they save?
ergo, if the GOP slowed down approval of bioequivalents, they probably saved lives.
Do You Own Research
--WC
All drugs have side effects, the stronger the drug, the worse the side effects. And many extremely expensive, widely used drugs are ING USELESS if not actually harmful.
ergo, the GOP saved lives by jamming up the pipeline and jacking up the cost.
you lose again.
you can GFY, over and over and over
The FDA is a total fraud, a sham, stuffed employees, doctors, scientists who are nothing more than BigPharma lobbyists and shills.
BigPharma tests its own drugs, suppresses bad results (which are kept secret), hypes good results, in trials with too few patients and for too short of test period. In effect new drugs are in beta test, and patients are nothing more than guinea pigs, Ms of whom have been maimed or killed, costing BigPharma $10Bs in fines and compensation, as nothing more than the cost of doing business.
The drugs are then also promoted by BigPharma and docs for off-label (totally untested) uses. It's all revenue.
Big frauds: all statins, and cardiac stents.
100s of stories like this over the decades
Big Pharma Company Mocked Patients Who Got "Jawbone Death" from Drug: "Ma Toot Hurts So Bad"
As early as 2004, Merck knew its blockbuster osteoporosis drug Fosamax was causing osteonecrosis of the jaw (ONJ) after in-office dental procedures and ridiculed afflicted patients. The condition, also called jawbone death, occurs when traumatized tissue doesn't heal but becomes "necrotic" and dies. "Ma toot hurts so bad" mimicked Merck bone scientist Don Kimmel in a 2004 email to Merck health science consultant Sharon Scurato about the type of patient who was developing ONJ. Such a patient "could be an oral hog," wrote Kimmel, then a bone scientist in Merck's department of Molecular Endocrinology/Bone Biology and trained as a dentist--someone with pre-existing infections and periodontal disease who omits preventative care.
Newly available emails and internal Merck do ents reveal the company was far from concerned or surprised when ONJ-links to Fosamax surfaced in the early 2000's and launched elaborate spin campaigns to keep the $3 billion a year pill afloat. In fact, animal studies revealed ONJ in rats given bisphosphonates (the class of drugs Fosamax belongs to) as early as 1977 Kimmel admitted under oath in 2008.
Thousands of lawsuits have been filed on behalf of patients who say they developed ONJ after dental procedures like tooth extraction because they took Fosamax. Treating ONJ is almost impossible said dentists and oral surgeons quoted the Review-Journal in 2005, because "further surgery in an effort to correct the problem only exacerbates it, leaving the patient with even more exposed bone and even more disfigured," Jaw removal, bone grafts, and even tracheostomies were reported by the News-Press in 2006. "Even short-term oral use of alendronate [Fosamax] led to ONJ in a subset of patients after certain dental procedures were performed,” read a study in the Journal of the American Dental Association in 2009.
Merck withheld crucial safety data from the American Society for Bone and Mineral Research (ASBMR) when the group sought to develop a position paper on bisphosphonate-related ONJ. Of 428 suspected ONJ cases related to Fosamax, 378 of which were highly likely to be ONJ, only 50 cases were shared with ASBMR, according to court do ents. "I see the 50 with regard to the postmarketing," admitted Thomas Bold, Merck's director of clinical risk management and safety surveillance in 2009, upon viewing the slides Merck provided to ASBMR. "I don't see 378 mentioned and I don't know why that is the case," he conceded.
http://www.alternet.org/print/drugs/...t-hurts-so-bad
yawn, another new BigPharma drug, another new ing over patients for $Bs in profits.
FDA refuses to FOLLOW EUROPE and ban BPA, due to BigChem corrupting FDA and Congress.
Study Shows BPA Exposure in Fetal Livers
BPA, or bisphenol A, in fetal liver tissue, demonstrating that there is considerable exposure to the chemical during pregnancy.
"The general message from our research is that people have to be cognizant of the fact that the adult body may be able to deal with a particular exposure but a developing fetus may not,"
Previous animal studies have associated BPA with breast and prostate cancer, and reproductive and behavioral abnormalities. Some research on effects to human health has tied BPA to cardiovascular disease, miscarriage, decreased semen quality and childhood behavioral issues. The chemical also may impact metabolism, diabetes and obesity, although more studies are required to determine its effects.
http://www.sciencedaily.com/releases...1203131658.htm
BPA, along with other BigChem's endocrine disruptors, has the wonderful effect of feminizing male fetuses. Measurements of male babies' anal-genital distance shows reduction towards female anal-genital distance, and of course smaller, less masculine genitals. But, BigChem's profits MUST be protected.
Whose job is it to maintain the anal-genital distance tables, I wonder?
Some job.
By the by... why did you post something from six years ago, Boutons? And do you really believe Pharma doesn't own the Dems, too?
Oh, I see... it was a necro-bump.
My mistake
job? why does it have to be anybody's job?
A fair point -- I hadn't considered the possibility of hobbyists tracking variations in anal-genital distances relative to gender over time.
Some hobby.
It's not a hobby. It's part of evaluating/measuring each newborn. The medical job is measuring, not maintaining anatomicial distances.
dup.
lol...thread lies dormant for 6 years (like most of the bot's posts) and WH revives it? ing Frankenstein!
BigPharma and its corrupt enforcer the FDA work to protect BigPharma's patented drug income against generics and importation of cheaper BigPharma drugs. Rest assured that BigPharma revenue is ALWAYS the BigPharma/FDA priority, NOT patient care.
TB!
The Repug/VRWC blind ideology of deregulation and non-enforcement works wonders for BigAg and BigFood, and of course, is a huge stimulus for the health care sector.
Why Isn't the FDA Stopping The Epidemic of Foodborne Illness?
he United States is experiencing what amounts to an epidemic of foodborne illnesses. According to the CDC, there are about 48 million cases of food poisoning a year, leading to more than 128,000 hospitalizations and more than 3,000 deaths. E. coli in spinach and fruit juice, salmonella in eggs and jalapeño peppers, listeria not only in cantaloupes but in cheese and bagged lettuce—the toll from foodborne bacteria is mind-numbing.
With the exception of E. coli infections, the rate of outbreaks from other pathogens tracked by the CDC has been rising since 2007. The decline in E. coli–related illnesses is in part the result of strong actions taken by the Department of Agriculture in 1994. Following an outbreak caused by tainted hamburger from the Jack-in-the-Box fast-food chain that killed four children, the agency declared E. coli 0157:H7, the strain that sickened the children, an adulterant, making it illegal for companies under USDA jurisdiction to sell food contaminated with the bug. Meat producers took measures to eliminate it from their facilities. But potentially fatal bacteria other than E. coli have yet to be declared adulterants.
Some of the FDA’s deficiencies can be attributed to the haphazard manner in which it has grown. In contrast to the Environmental Protection Agency, which was created in 1970 to bring all federal environmental activities into a single, powerful unit with a clear mandate, the FDA expanded and occasionally contracted over decades in response to crises and pressure from public interest groups and corporate lobbyists. The agency originated in 1852, when it consisted of a single chemist working in the Department of Agriculture. It had no regulatory duties until 1906, when muckraking journalists’ horror stories [4] about food-processing facilities inspired passage of the Federal Food and Drugs Act. In 1937, hundreds of deaths from a new sulfa drug propelled passage of the Food, Drug, and Cosmetic Act to prevent similar health disasters. In the 1950s and 1960s, laws addressing pesticide residues, food additives, and color additives gave the agency greater control over food safety.
The FDA considers fresh produce to be "high risk" and therefore a priority for inspection. But until people started dropping dead, the Jensen facility had never once in its 20-year history been inspected by the FDA. Like most produce companies, Jensen used third-party auditors to certify its handling systems. On July 25, at about the same time the first people were being sickened by contaminated cantaloupe, one such auditor, a representative of Bio Food Safety [7], a Texas-based company whose website advertises "quality service at an unbelievable price," visited Jensen for four hours and blessed the plant with a "superior" rating of 96 percent.
http://www.motherjones.com/print/209291
FWIW the top drug companies pretty much contribute equally to Dems and Repubs.
they can afford it, with about the highest profit margins of the Top200, and after spending $60B on advertising and half as much on research/testing.
It's exclusively the Repugs who blame their hated govt and regulations for all that ills USA, not the Dems.
Boo loves his government?
I can't construct a cogent sentence.
Here's yet another gift from corporate BigAg, BigChem, BigFood
Scientists Warn of Sperm Count Crisis
Between 1989 and 2005, average sperm counts fell by a third in the study of 26,000 men, increasing their risk of infertility. The amount of healthy sperm was also reduced, by a similar proportion.
The decline occurred progressively hroughout the 17-year period, suggesting that it could be continuing.
"Now, there can be little doubt that it is real, so it is a time for action. Something in our modern lifestyle, diet or environment is causing this and it is getting progressively worse. We still do not know which are the most important factors but the most likely are … a high-fat diet and environmental chemical exposures."
Sperm count: How to boost it
1. Wear loose underwear – to make healthy sperm the testicles need to be below body temperature.
2. Eat food low in saturated fat.
3. Avoid smoking, drinking, using drugs and becoming obese.
4. Reduce exposure to industrial chemicals such as those used in making plastics – they can mimic the female hormone oestrogen countering male hormones.
http://www.alternet.org/personal-hea...m-count-crisis
"Eat food low in saturated fat" should be qualified to "Eat food low in mammalian, industrial saturated fat".
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