Imports From Indian Drug Maker Halted
By THE ASSOCIATED PRESS
WASHINGTON (AP) — The government blocked the importation of more than 30 generic drugs, including popular antibiotics and cholesterol medicines, made by India’s biggest pharmaceutical company, citing poor quality in two of its factories.
The Food and Drug Administration’s move does not end United States sales by the drug maker, Ranbaxy Laboratories. Instead, it blocks imports of generic drugs, including generic versions of the antibiotic Cipro and the cholesterol pill Zocor, as well as pharmaceutical ingredients made at the two suspect plants in India.
F.D.A. inspections this year found violations that could lead to contamination, allergic reactions and other problems, and the company has failed to take proper steps to correct them, said Deborah Autor, director of F.D.A.’s compliance office.
Also, the F.D.A. said it would not approve any new products for sale by Ranbaxy until the manufacturing violations are corrected.
The F.D.A. told consumers who have Ranbaxy products at home not to worry or quit using them: Repeated testing has not found any contaminated products, just the threat of them if factory conditions do not improve. Also, it would be hard for a patient to tell if drugs were made at the suspect factories or at one of Ranbaxy’s numerous other factories in 11 countries.
”We have seen no evidence of harm to consumers from drugs produced at these two facilities and have no reason to believe that drugs already in the U.S. from these plants pose a safety problem,” said F.D.A. deputy drug director Dr. Douglas Throckmorton.
The factories with defects are in Dewas and Paonta Sahib, India.
Thursday, September 18, 2008
Monday, September 15, 2008
Lobbying on Prescription drugs
Novo Nordisk spent $350,000 lobbying in 2Q
Thursday August 28, 11:21 am ET
Drugmaker Novo Nordisk spent $350,000 lobbying government in second quarter
WASHINGTON (AP) -- Danish drugmaker Novo Nordisk AS spent $350,000 lobbying the U.S. government in the second quarter, according to a recent disclosure report.
The company lobbied on drug importation, patient safety protection, a bill to reduce health disparities, patent reform, diabetes patient care, and the Medicare Prescription Drug Price Negotiation Act, among other topics.
Novo Nordisk lobbied Congress, the Patent and Trademark Office, Department of Health and Human Services, Centers for Medicare and Medicaid Services, and the Office of Management and Budget.
Among those registered to lobby for Novo Nordisk in the April-June period was Lauren Semeniuk, who used to be legislative director for Rep. Cliff Stearns, R-Fla.
The company spent $330,000 lobbying on many of the same issues in the first quarter.
Thursday August 28, 11:21 am ET
Drugmaker Novo Nordisk spent $350,000 lobbying government in second quarter
WASHINGTON (AP) -- Danish drugmaker Novo Nordisk AS spent $350,000 lobbying the U.S. government in the second quarter, according to a recent disclosure report.
The company lobbied on drug importation, patient safety protection, a bill to reduce health disparities, patent reform, diabetes patient care, and the Medicare Prescription Drug Price Negotiation Act, among other topics.
Novo Nordisk lobbied Congress, the Patent and Trademark Office, Department of Health and Human Services, Centers for Medicare and Medicaid Services, and the Office of Management and Budget.
Among those registered to lobby for Novo Nordisk in the April-June period was Lauren Semeniuk, who used to be legislative director for Rep. Cliff Stearns, R-Fla.
The company spent $330,000 lobbying on many of the same issues in the first quarter.
Wednesday, June 25, 2008
Walmart importing drugs from India
In 2003, a new kind of "drugstore" appeared across America, promoting cheaper prescription drugs from Canada. Instead of pills, these stores had fax machines and computers that could process orders from senior citizens in the U.S. desperately seeking lower cost drugs.
But federal and state regulators stepped in to interrupt the supply chain. "To some extent, we're caught in the middle of a problem that is not our responsibility, which is drug prices. Our responsibility is safety," a Food and Drug Administration (FDA) official, told USA Today. The FDA issued warning letters to these storefront pharmacies, saying importing Canadian drugs violated federal law. At the time, at least one million Americans were sourcing their medications from Canada. More than $1 billion in product was being imported from Canadian suppliers. The FDA ruled that anyone enabling U.S. citizens to buy drugs from other countries was violating federal law. Storefront owners countered that they were not violating the law, because they were not dispensing drugs -- just helping customers with paperwork.
The pharmaceutical industry was largely seen as driving the FDA to be more aggressive on cross-border imports, because of the potential loss of profits. But the FDA said its concerns about drugs entering the U.S. were all about safety. Seniors were warned that their drugs could be counterfeit, or from countries with weak regulatory standards. "They allege these are Canadian versions of drugs approved in the United States, but we don't know what they are, because there is no regulatory oversight of these drugs," the FDA told USA Today. The importers insisted that the drugs were coming from licensed Canadian pharmacies.
One Oklahoma-based importer, Rx Depot, was shut down by the FDA for violating drug importation laws. A federal judge ordered 85 Rx Depot stores closed in 2004, ruling that only drug manufacturers were allowed to import drugs for sale. The court also ruled that the safety of these imported drugs could not be verified. Rx Depot appealed the court's decision. "We're going to fight like a wild animal," one of Rx Depot's co-founders said---but the stores never reopened. To stop cross-border selling, some drug manufacturers, like GlaxoSmithKline, stopped shipping drugs to Canadian wholesalers who sold to U.S. customers. That led elderly rights groups to call for a boycott of Glaxo.
Beginning January 1, 2006, the entire drug importation issue changed dramatically with the implementation of Medicare Part D by Congress. Talk of Canadian imports all but disappeared from the media. Within 9 months of the creation of Medicare's new drug program, Wal-Mart announced that it would begin selling in the Tampa, Florida trade area, a month's supply from a list of 150 generic drugs for $4 each. One industry analyst told the NewsHour that Wal-Mart's drugs "come from all over the world. They're U.S. manufacturers, Israeli and Indian manufacturers. They have a choice of where to buy these drugs. They are the lower cost drugs in the system today, and that's part of the reason why they're able to price them at this low price point." Wal-Mart was buying drugs directly from manufacturers.
By the end of April of 2007, Planet Retail was reporting that Wal-Mart was "in advanced talks" with the largest Indian pharmaceutical exporting companies -- unknown to most Americans -- like Ranbaxy, Dr. Reddy's Labs, Cipla, Lupin and Sun Pharma. In March of 2003, the Los Angeles Business Journal reported that Cipla and Ranbaxy had 81 applications before the FDA to sell generic drugs in the United States. The companies were taking advantage of India's low labor costs and highly-skilled work force to expand outside their home base. Ranbaxy had challenged the patents on blockbuster drugs such as Pfizer's Lipitor and AstraZeneca's Nexium. A U.S. district court ruled in favor of Pfizer, but Ranbaxy appealed the decision. Even if it ends up losing the challenge, Ranbaxy will be the only generic manufacturer for six months after the patent expires, because under FDA law, the first company to file a challenge on a patent has six-month exclusivity rights, during which time the generic price can be as high as 80% of the original drug. This position could be worth billions to Ranbaxy.
About 14.3% of unapproved medicines entering the US market come from India, according to a group called GS1, a global organization "dedicated to the design and implementation of global standards" to improve the efficiency of supply chains globally. GS1 is described as a joint industry-Government initiative to bring international best practices into India. Wal-Mart began requiring its drug suppliers to use radio frequency identification tags (RFIDs) to help track drug supplies, and check counterfeits.
Historically, according to Bain & Company, Indian companies would copy drugs from other companies and make inexpensive versions, because the Indian government required the indigenous manufacturers to adhere to foreign patents on the manufacturing process, but not on the final drug product. They could alter the manufacturing process and produce generic versions of foreign branded drugs even while they were under patent. But India' laws have been amended to prevent big generic manufacturers like Ranbaxy from making inexpensive copies of foreign drugs patented after 1995.
A drug industry group called Pharmexcil, set up in December of 2004 by India's Ministry of Commerce & Industry, says that Indian drug makers have "tremendous opportunities...in the post 2005 era to manufacture and export many products getting off-patented. Its immense strength [is] in manufacturing quality medicines at affordable prices." According to Pharmexcil, "The generic drug prices in the US market have substantially gone down with Indian generic players quoting low prices...It is good to see that the quality of Indian generic products are accepted in the US."
In 2005, Ranbaxy won Wal-Mart's Supplier Award for outstanding performance. Ranbaxy expects that its U.S. division, largely buoyed by Wal-Mart, will bring in 50% of the corporation's revenues. The Indian drug company's sales in the U.S. increased ten-fold from 1999 to 2003, according to Bain.
From this complex global manufacturing and distribution network, a few basic facts emerge:
· * most Americans have no idea that the drugs they are buying at Wal-Mart are produced in India, made by companies that are copying another company's products.
· * although India has the highest the number of U.S. FDA-approved facilities (84) outside the U.S., no one knows how reliable the quality of Indian drugs really are. The World Health Organization (WHO) has warned that the global counterfeit and substandard drug trade is a $35-billion business, with little risk of prosecution.
· * when consumers buy their drugs at Wal-Mart, the retailer uses that money to buy more products from India, in the same way they buy more clothing or toys from China. Once again, the U.S. takes what other countries make. Wal-Mart's sourcing of drugs from foreign countries exacerbates our unprecedented foreign trade imbalance.
Ironically, the same federal government that hassled senior citizens over importing small quantities of drugs from Canada, now seems content to allow Wal-Mart to import billions of dollars annually worth of Indian drugs to enhance the retailer's bottom line. The Indian drug companies have found a generic drug niche to fill, and they are using their poorly-paid workforce and less than stringent regulatory requirements to satisfy America's growing need for pills. Unlike clothing or toys---there is no label on the pill that says "made in India."
Al Norman is the founder of Sprawl-Busters, and the author of "The Case Against Wal-Mart."
But federal and state regulators stepped in to interrupt the supply chain. "To some extent, we're caught in the middle of a problem that is not our responsibility, which is drug prices. Our responsibility is safety," a Food and Drug Administration (FDA) official, told USA Today. The FDA issued warning letters to these storefront pharmacies, saying importing Canadian drugs violated federal law. At the time, at least one million Americans were sourcing their medications from Canada. More than $1 billion in product was being imported from Canadian suppliers. The FDA ruled that anyone enabling U.S. citizens to buy drugs from other countries was violating federal law. Storefront owners countered that they were not violating the law, because they were not dispensing drugs -- just helping customers with paperwork.
The pharmaceutical industry was largely seen as driving the FDA to be more aggressive on cross-border imports, because of the potential loss of profits. But the FDA said its concerns about drugs entering the U.S. were all about safety. Seniors were warned that their drugs could be counterfeit, or from countries with weak regulatory standards. "They allege these are Canadian versions of drugs approved in the United States, but we don't know what they are, because there is no regulatory oversight of these drugs," the FDA told USA Today. The importers insisted that the drugs were coming from licensed Canadian pharmacies.
One Oklahoma-based importer, Rx Depot, was shut down by the FDA for violating drug importation laws. A federal judge ordered 85 Rx Depot stores closed in 2004, ruling that only drug manufacturers were allowed to import drugs for sale. The court also ruled that the safety of these imported drugs could not be verified. Rx Depot appealed the court's decision. "We're going to fight like a wild animal," one of Rx Depot's co-founders said---but the stores never reopened. To stop cross-border selling, some drug manufacturers, like GlaxoSmithKline, stopped shipping drugs to Canadian wholesalers who sold to U.S. customers. That led elderly rights groups to call for a boycott of Glaxo.
Beginning January 1, 2006, the entire drug importation issue changed dramatically with the implementation of Medicare Part D by Congress. Talk of Canadian imports all but disappeared from the media. Within 9 months of the creation of Medicare's new drug program, Wal-Mart announced that it would begin selling in the Tampa, Florida trade area, a month's supply from a list of 150 generic drugs for $4 each. One industry analyst told the NewsHour that Wal-Mart's drugs "come from all over the world. They're U.S. manufacturers, Israeli and Indian manufacturers. They have a choice of where to buy these drugs. They are the lower cost drugs in the system today, and that's part of the reason why they're able to price them at this low price point." Wal-Mart was buying drugs directly from manufacturers.
By the end of April of 2007, Planet Retail was reporting that Wal-Mart was "in advanced talks" with the largest Indian pharmaceutical exporting companies -- unknown to most Americans -- like Ranbaxy, Dr. Reddy's Labs, Cipla, Lupin and Sun Pharma. In March of 2003, the Los Angeles Business Journal reported that Cipla and Ranbaxy had 81 applications before the FDA to sell generic drugs in the United States. The companies were taking advantage of India's low labor costs and highly-skilled work force to expand outside their home base. Ranbaxy had challenged the patents on blockbuster drugs such as Pfizer's Lipitor and AstraZeneca's Nexium. A U.S. district court ruled in favor of Pfizer, but Ranbaxy appealed the decision. Even if it ends up losing the challenge, Ranbaxy will be the only generic manufacturer for six months after the patent expires, because under FDA law, the first company to file a challenge on a patent has six-month exclusivity rights, during which time the generic price can be as high as 80% of the original drug. This position could be worth billions to Ranbaxy.
About 14.3% of unapproved medicines entering the US market come from India, according to a group called GS1, a global organization "dedicated to the design and implementation of global standards" to improve the efficiency of supply chains globally. GS1 is described as a joint industry-Government initiative to bring international best practices into India. Wal-Mart began requiring its drug suppliers to use radio frequency identification tags (RFIDs) to help track drug supplies, and check counterfeits.
Historically, according to Bain & Company, Indian companies would copy drugs from other companies and make inexpensive versions, because the Indian government required the indigenous manufacturers to adhere to foreign patents on the manufacturing process, but not on the final drug product. They could alter the manufacturing process and produce generic versions of foreign branded drugs even while they were under patent. But India' laws have been amended to prevent big generic manufacturers like Ranbaxy from making inexpensive copies of foreign drugs patented after 1995.
A drug industry group called Pharmexcil, set up in December of 2004 by India's Ministry of Commerce & Industry, says that Indian drug makers have "tremendous opportunities...in the post 2005 era to manufacture and export many products getting off-patented. Its immense strength [is] in manufacturing quality medicines at affordable prices." According to Pharmexcil, "The generic drug prices in the US market have substantially gone down with Indian generic players quoting low prices...It is good to see that the quality of Indian generic products are accepted in the US."
In 2005, Ranbaxy won Wal-Mart's Supplier Award for outstanding performance. Ranbaxy expects that its U.S. division, largely buoyed by Wal-Mart, will bring in 50% of the corporation's revenues. The Indian drug company's sales in the U.S. increased ten-fold from 1999 to 2003, according to Bain.
From this complex global manufacturing and distribution network, a few basic facts emerge:
· * most Americans have no idea that the drugs they are buying at Wal-Mart are produced in India, made by companies that are copying another company's products.
· * although India has the highest the number of U.S. FDA-approved facilities (84) outside the U.S., no one knows how reliable the quality of Indian drugs really are. The World Health Organization (WHO) has warned that the global counterfeit and substandard drug trade is a $35-billion business, with little risk of prosecution.
· * when consumers buy their drugs at Wal-Mart, the retailer uses that money to buy more products from India, in the same way they buy more clothing or toys from China. Once again, the U.S. takes what other countries make. Wal-Mart's sourcing of drugs from foreign countries exacerbates our unprecedented foreign trade imbalance.
Ironically, the same federal government that hassled senior citizens over importing small quantities of drugs from Canada, now seems content to allow Wal-Mart to import billions of dollars annually worth of Indian drugs to enhance the retailer's bottom line. The Indian drug companies have found a generic drug niche to fill, and they are using their poorly-paid workforce and less than stringent regulatory requirements to satisfy America's growing need for pills. Unlike clothing or toys---there is no label on the pill that says "made in India."
Al Norman is the founder of Sprawl-Busters, and the author of "The Case Against Wal-Mart."
Thursday, March 13, 2008
A view on Reimporting Prescrption Drugs
Importing drugs is cowardly and makes no sense.
Cowardly, because politicians who back Rx imports are really seeking to import price controls, without saying so.
Makes no sense because US demand would quickly overwhelm the drug supply and drive prices up in the targeted countries: Canada, Ireland, New Zealand. And the locals won’t permit that.
Americans are wealthy and smart enough to figure this out themselves. And Americans also don’t want to lose world leadership in pharma R&D (and jobs).
Ask Europe how medical-pharma R&D & investment have gone, since they restricted Rx prices and patient access to treatment.
That said, pharma needs a new longer-term value proposition, for sure.
Comment by Cam Battley - March 12, 2008 at 4:39 pm
Cowardly, because politicians who back Rx imports are really seeking to import price controls, without saying so.
Makes no sense because US demand would quickly overwhelm the drug supply and drive prices up in the targeted countries: Canada, Ireland, New Zealand. And the locals won’t permit that.
Americans are wealthy and smart enough to figure this out themselves. And Americans also don’t want to lose world leadership in pharma R&D (and jobs).
Ask Europe how medical-pharma R&D & investment have gone, since they restricted Rx prices and patient access to treatment.
That said, pharma needs a new longer-term value proposition, for sure.
Comment by Cam Battley - March 12, 2008 at 4:39 pm
Monday, March 10, 2008
Drugs on line
President Bush last weekend called on Congress to pass legislation that would restrict the online sales of prescription drugs, but the president's request addresses "a symptom and not the cause of one of the country's top medical problems": the high cost of medications in the U.S., Los Angeles Times columnist David Lazarus writes. According to Lazarus, many U.S. residents, "including numerous seniors and people with chronic conditions, obtain prescription drugs from international sources not because they're scratching some itch for faraway places," but because "they can't afford U.S. drug prices."
Thursday, February 28, 2008
Imports from China
Even so, the problems involving heparin have again focused attention on the quality of products from China and the gaps in regulation by both the Chinese and United States governments. S.P.L.’s plant in Changzhou was certified by American officials to export to the United States even though neither government had inspected it. The plant has been exporting heparin to Baxter since 2004.
Like many chemical companies in China that make pharmaceutical ingredients for export, S.P.L. fell into a regulatory void. A spokesman for China’s State Food and Drug Administration, Shen Chen, said his agency had not inspected the S.P.L. factory because “as far as we know, it is not a drug manufacturer; it is a producer of chemical ingredients.” Mr. Shen said his agency was helping American investigators as part of a recent agreement with American regulators.
Like many chemical companies in China that make pharmaceutical ingredients for export, S.P.L. fell into a regulatory void. A spokesman for China’s State Food and Drug Administration, Shen Chen, said his agency had not inspected the S.P.L. factory because “as far as we know, it is not a drug manufacturer; it is a producer of chemical ingredients.” Mr. Shen said his agency was helping American investigators as part of a recent agreement with American regulators.
Wednesday, February 27, 2008
CANADIAN DRUG RE IMPORTATION
TSCL & Drug Reimportation
The implementation of the Medicare Part D prescription drug benefit led some in Congress to believe that the prescription drug situation was solved for most seniors. So, it became more difficult to garner support in Congress for reimportation bills at the end of the 109th session. However, the overall results of the Medicare Part D drug benefit have not yet been fully determined.
Simply put, pharmaceutical companies have been over-charging the American consumer for prescription drugs compared with costs for the same drugs in Canada and Europe. Pharmaceutical companies have made bulk deals with governments (such as Canada) where they still make substantial profits while charging much less for prescriptions.
TSCL believes that this is not a safety issue. Rather, it's an issue of pharmaceutical companies charging excessive prices in part due to their extraordinary clout and influence in the political process. TSCL supported bills in the House (H.R. 328) and Senate (S.334 and S.109) that would - in our view - make safe and secure prescription drug reimportation a reality.
The implementation of the Medicare Part D prescription drug benefit led some in Congress to believe that the prescription drug situation was solved for most seniors. So, it became more difficult to garner support in Congress for reimportation bills at the end of the 109th session. However, the overall results of the Medicare Part D drug benefit have not yet been fully determined.
Simply put, pharmaceutical companies have been over-charging the American consumer for prescription drugs compared with costs for the same drugs in Canada and Europe. Pharmaceutical companies have made bulk deals with governments (such as Canada) where they still make substantial profits while charging much less for prescriptions.
TSCL believes that this is not a safety issue. Rather, it's an issue of pharmaceutical companies charging excessive prices in part due to their extraordinary clout and influence in the political process. TSCL supported bills in the House (H.R. 328) and Senate (S.334 and S.109) that would - in our view - make safe and secure prescription drug reimportation a reality.
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