Generic Drugs
For additional information on this topic please see our
article "Branded"
Generic Drugs".
Please also see our article "Patents and the Possibility of
Generic Biologic Drugs"- Part III of a III Part Series
(9/9/11)- Ralph G. Neas has been named the new chief executive of the Generic Pharmaceutical Association, a Washington-based industry group representing generic drug makers and suppliers.
Mr. Neas, 65, is best known for leading the fight against President Ronald Reagan's nomination of Judge Robert H. Bork to the Supreme Court. He was a past executive director of the Leadership Conference on Civil Rights for more than a dozen years, and he also served as president and chief executive for People for the American Way until a few years ago.
His last position was as the chief executive of the National Coalition on Health Care, a group with broad support from business, unions and others.
Mr. Neas succeeds Kathleen Jaeger, who left the association last year.
(8/18/11)- It now appears likely that an agreement that was reached between the federal government and the generic drug industry will lead to periodic routine inspections of overseas drug ingredient plants. The agreement has to be approved by Congress but most political experts think that the legislation will be forthcoming.
Under the landmark agreement, the generic drug industry would pay $299 million in annual fees to underwrite the cost of the inspections of foreign manufacturing plants every two years, the same frequency required of domestic plants.
The agreement will not affect the manufacturing of over-the-counter drugs or vitamins. Aspirins and vitamin C supplements for example are now made almost entirely in uninspected plants in China.
The funding will also be used to expedite the approval time for generic drugs since it now takes about 31 months for the agency to approve a generic drug. There are now 2,458 applications awaiting approval, up from 2,361 at the end of last year. The new funding is expected to bring the approval time down to 10months.
The generic drug fees will be included in a package of fees for the branded drug industry, as well as the medical device industry that is expected to be presented to Congress by the Obama administration in early January.
The funding legislation must pass before October 2012, or numerous FDA functions will halt.
(7/7/11)- The U.S. Supreme Court, by a 5-4 vote, reversed the decision of the lower court in the Pliva Inc. vs. Mensing, No. 09-993 case that we discussed in our item dated 4/4/11. Generic drug companies can not change the label for the drug as written by the branded name drug company, and therefore can not be held liable if the drug in question harms the user.
Brand name drug companies can be sued under state law for failing to update a drug's label when its adverse affects become known after the FDA approves its usage. Under the Pliva ruling, generic drug companies can't be sued for failing to change a drug's label, even though it may have become aware of negative side effects from usage of the drug.
The drug in question was metoclopramide, a drug used to treat digestive tract problems like reflux and originally sold after its 1980 approval under the brand name of Reglan. Evidence showed that the drug's long term usage caused tardive disorder that is characterized by repetitive and involuntary movements.
(4/4/11)- The Supreme Court recently heard oral arguments in 3 consolidated cases involving the question as to whether or not generic drug makers can be sued in state courts for failure to warn users of their products as to the negative side effects, even though the Food and Drug Administration (FDA) has approved the label for the drug.
Generic drug makers are not allowed to change the particulars contained in the drug label that has been approved by the FDA.
In the case of Wyeth vs. Levine, the court ruled that makers of brand-name drugs could be sued under state law for failure to warn consumers about the risks associated with a particular drug. The court relied heavily on the fact that brand-name drug companies can sometimes change the labels on their products without permission from the FDA.
A generic drugs must be the "bio-equivalent" of its brand-name drug.
In the three consolidated cases that were heard by the court, including Pliva Inc. vs. Mensing, No. 09-993, women who took the generic equivalent of Reglan for stomach ailments developed a serious neurological disorder. The lower appeals court ruled against the generic drug manufacturer, saying that the federal regulatory regime did not block claims under the state law.
In arguing for the generic drug company, Jay P. Lefkowitz said: "Generics can't simultaneously comply with a federal duty to be the same and a state duty to be different."
(2/24/11)- With the brand name drug companies facing the loss of patent protection within the next 2 years of 5 blockbuster drug patents, the generic drug industry now strongly supports the payment by its industry of user fees system to be used to speed up the approval of generic drugs and generic plant inspections similar to what already exists for the brand name drug industry.
The generic drug industry estimates that it now takes about 2 1/2 years on average to gain FDA approval to sell their drugs. Negotiations between the industry and the Food and Drug Administration are scheduled to begin on February 28.
Generic drugs accounted for about 75% of all prescription medications sold in this country in 2010.
According to figures from the FDA, U.S. drug plants are inspected about every two years after they have been certified, while foreign facilities are not inspected for much longer periods of time. The latest figures from the FDA show that about 40% of the drugs in the U.S. are imported.
A government report in 2010 stated that about 64% of the 3,700 foreign drug facilities may never have been inspected by the agency. The Obama administration has supported user fees for generic drugs, as shown by the fact that his proposed budget included $40 million in anticipated revenue from such fees in 2012.
(4/22/10)- For the second time within a year, the U.S. Food and Drug Administration (FDA) sent a warning letter to Apotex Inc., Canada's biggest drug company concerning safety violations at its manufacturing plant in Toronto. The earlier violations had occurred at the company's manufacturing facility in Etiobicoke, Ontario in 2008.
Apotex is the eighth-largest provider of generics in this country with sales last year of $879 million, according to IMS Health, the drug-data firm. The letter also said the company had failed t notify regulators in a timely fashion about the problems.
In 2009, Apotex filled 94 million prescriptions in the U.S., according to IMS. Generic drugs account for 75% of the total prescriptions filled in this country in 2009.
According to the law, it is illegal to bring Canadian drugs into this country even if it is for your own use. Whenever legislation has been introduced in Congress to allow the importation of Canadian drugs into the country, opponents have used the safety of foreign drugs to defeat passage of the law.
(9/23/08)- The U.S. Food and Drug Administration banned imports of more than 30 generic drugs made by Ranbaxy Laboratories Ltd., of India, because of concerns about the "seriousness and extent" of violations at two Ranbaxy plants in India. Consumers will not be affected by the bans because the drugs can be supplied by other generic drug makers, with the exception of the company's AIDS drug called Ganciclovir for which the company is the sole supplier in the United States.
Ranbaxy is the largest generic drug manufacturer in India with worldwide sales of $1.62 billion in 2007, of which $400 million took place in the U.S. The Japanese drug company Daiichi Sankyo Co., is in the process of taking over Ranbaxy in a $4.6 billion deal that is awaiting Indian governmental approval.
Ranbaxy is presently under investigation by the U.S. Justice Department for allegations of improperly manufacturing HIV drugs that were given to thousands of AIDS patients in Africa.
It is unclear whether the ban might affect Ranbaxy's six-month exclusivity deal to produce Lipitor, Pfizer Inc.'s blockbuster cholesterol drug that comes off patent protection in 2011
Indian pharmaceutical exports are projected to hit $10 billion this year, up from $1.9 billion in 1999, according to Global Trade Information Systems, a U. S. supplier of international trade data, and IDFC-SKKI Securities, a Mumbai brokerage firm.
(5/2/08)- Melinda Beck wrote a recent article in the Health Journal column of the Wall St Journal entitled "Inexact Copies: How Generics Differ From Brand Names"
In the article Ms. Beck discusses the fact the human body may have different reactions to generic drugs from their reaction to brand name drugs. A main part of the article discussed what has what happened after Wellbutrin, the antidepressant drug made by Biovail Corp. of Canada, and marketed by GalxoSmithKline PLC of England, the generic version of this drug, named Budeprion XL 300 came onto the market. Budeprion XL is distributed by Teva Pharmaceuticals USA, the American subsidiary of the Israeli generic drug company Teva Pharmaceuticals.
The FDA approved a Budeprion XL in December 2006, and the drug immediately impacted the sales of Wellbutrin. The article pointed out, "But patients soon started logging complaints about Budeprion at PeoplesPharmacy,com, a Web site that has become a clearing house for medication gripes."
Joe Graedon, a pharmacist who runs People's Pharmacy with his wife alerted the FDA and also asked ConsumerLab.com to run a test on Budeprion. Consumer Labs found that Budeprion dissoves faster, releasing 34% of the drug within the first two hours, compared with 8% for Wellbutrin.
Generics must have the same bioequivalency as the brand name drug, and thus they avoid the strenuous testing requirements that the FDA imposes before it will approve a drug for usage in the market. According to FDA guidelines the generic can produce blood levels as much as 20% below or 25% above the branded drug.
According to data from the Generic Pharmaceutical Association, a trade group for the generic drug industry, about 65% of all prescription drugs dispensed are for generic versions of the drugs.
The FDA conducted an investigation of the Wellbutrin matter and found that there was only "small differences" between it and the generic drug. Critics of the FDA report however said that the FDA relied on tests comparing a lower dosage of Wellbutrin and Budaprion- 150 mg-when it first approved the 300 mg version in 2006. The agency therefore did not have specific bioequivalence data on the 300- mg dose that had generated the complaints.
Bioequivalence tests are conducted on healthy people, not those who need the medication, according to FDA officials.
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Allan Rubin
updated September 9, 2011
http://www.therubins.com
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