Generic Drug

It was boom times last year for Lemmon Co. And the Sellersville generic-drug maker has U.S. patent laws to thank. The company launched seven new medicines in 1992 - more than ever before. But each was a copy of a drug that had been made only as a brand-name drug - that is, until their patents expired recently. So successful were Lemmon's new products that the company's sales grew by 40 percent last year, transforming the 46-year-old company into a major generic-drug maker, with annual sales of $100 million.

I'M AN admirer of Michelle Malkin, but I'm disturbed by her drug industry column of Oct. 18. First I would ask, how many shares of drug industry stock does she have in her portfolio. Second, how can an industry that makes multi-billions in profits, spend hundreds of million in advertising, another hundreds of million buying off generic drug makers and pay in the hundreds of million for campaign financing then cry poor mouth when questioned about the cost of their drugs to the working class and poor of this nation?

After only a few minutes of listening to Dr. Emerita T. Gueson, the 20 Natural Food Association members prepared to wage a battle against the multimillion-dollar generic-drug industry. As Gueson spoke Thursday about the hazards of generic drugs, Felicia Schnipper, executive director of the association, prepared a petition calling for better industry controls. "Generic drugs are not the same as brand-name drugs," said Gueson, an outspoken physician with obstetrics/gynecology practices at Nazareth Hospital in the Northeast and Holy Redeemer Hospital in Montgomery County.

Saying that "the generic-drug scandal is not abating," Rep. John D. Dingell (D., Mich.) yesterday criticized the Food and Drug Administration after two makers of generic drugs admitted further improprieties. Pharmaceutical Basic Inc., of Denver, and Duramed Pharmaceuticals, of Cincinnati, said they were withdrawing more of their products from the market. Pharmaceutical Basic was barred from doing business with the Defense Department during 1990 because of a bribery scandal and was reinstated to the government contractors' list only two weeks ago. It said it was halting distribution of all its products after discovering new evidence of falsifications by its employees in documents being submitted to the FDA. In 1989 and last year, two Pharmaceutical Basic officials pleaded guilty to bribing FDA employees in an attempt to gain rapid approvals of generic drugs.

Soon after one competitor conceded it had cheated in testing its generic version of SmithKline Beecham's Dyazide and the same day similar concerns were raised about another rival, SmithKline lashed out. "This news certainly reaffirms the necessity for dispensing your Dyazide prescriptions with the branded product," SmithKline wrote pharmacists amid the revelations that its high-blood-pressure medication had been substituted for the generic version...

The troubles hounding the generic-drug industry deepened yesterday when Food and Drug Administration inspectors told a congressional subcommittee that they had found a multitude of manufacturing problems in 11 of 13 firms under investigation. The problems outlined to the House Energy and Commerce investigations subcommittee included sloppy record-keeping, inconsistent test data, poor production practices and falsified information submitted to the FDA. The violations varied among the 11 firms.

Serious problems of fraud and other misconduct remain in the generic-drug industry despite a two-year federal investigation, officials said yesterday. Generic drugs are lower-cost substitutes for brand-name prescription drugs. Federal regulations require that generics be equivalent to the higher-priced brand names, both in terms of their effectiveness in treating illnesses and their shelf life. Many doctors routinely prescribe generics to help patients save money. Federal authorities, in their investigation, found that some generic-drug officials were bribing Food and Drug Administration officers to speed approval of inadequately tested products.

Driven by health insurers' push for lower-cost prescription drugs and expiring patents on top-selling brand-name medicines, makers of generic drugs have come into their own. "Once the 98-pound weaklings of the pharmaceutical industry," said Standard & Poor's analyst Arthur Wong, generic-drug companies now are competing aggressively and giving giant pharmaceutical companies "a run for their money. " And their drugs. Generics account for 42 percent of all prescriptions dispensed, and that number should inch up in the coming years, according to Doug Long, vice president of industry relations for IMS Health, a health-care information company with major operations in Plymouth Meeting.

The confusion is still there. It doesn't matter that for months the U.S. Food and Drug Administration has investigated the generic-drug industry and so far concluded that only a handful of companies were involved in wrongdoing. The industry continues to wrestle with image problems caused by revelations of falsified test results, sloppy record-keeping and other mismanagement. At Germantown Pharmacy in Philadelphia, customers have become increasingly nervous about generics, the discount drugs that are almost identical to more expensive brand-name versions.

The reputation of generic drugs partly hangs on the outcome of tests being done in Philadelphia and about a dozen other cities in the United States. So far, it seems, the tests are not further soiling the name of generics. The generic drugs analyzed at the Philadelphia office of the Food and Drug Administration haven't triggered any alarm bells that would suggest they have been improperly made, FDA officials say. The same holds for tests at the other labs of the FDA, which is continuing to test samples of about 75 percent of the most-prescribed generic drugs.

Teva Pharmaceuticals Ltd.'s new chief executive officer, Jeremy Levin, said Thursday that he has changed the leadership lineup in hopes of regaining more of the U.S. generic drug market, in which Teva has dominated for years but now faces increasing competition. Chief financial officer Eyal Deshah said the company has "instituted a cost-cutting and efficiency program throughout Teva's operations," but a spokeswoman later said via e-mail that there have been no new layoffs, including in the Americas division, which encompasses facilities in the Philadelphia area.

In the Region Generic drugmaker Watson Pharmaceuticals Inc. said Monday that it is seeking approval from the Food and Drug Administration to market a generic version of Abbott Laboratories' cholesterol drug Niaspan. Watson is looking to market Niacin extended-release tablets in 500mg and 1000mg versions. Niaspan had about $1.2 billion in U.S. sales for the year ended Jan. 31, according to IMS Health. On Friday, Abbott Laboratories and Abbott Respiratory L.L.C., which have operations in the Philadelphia area, filed a lawsuit against Watson to prevent the company from commercializing its generic product before the Niaspan patent expires.

Question: My husband has been taking Viagra for years. As you know, it is very expensive and there is no generic here in the United States. I heard on the radio that there is a much cheaper Viagra available. It is one-fourth the price of brand-name Viagra. What I received is "Fiagra. " It is from India. When I called the distributor, they said it's exactly the same. Have you heard of it? Is it safe? Answer: Viagra is not yet available in a generic form in the United States.

Cephalon Inc. is under investigation again for alleged off-label marketing of a drug. The Frazer-based pharmaceutical company told the Securities and Exchange Commission in a filing Monday that it received a subpoena from the U.S. Attorney's Office for the Southern District of New York, seeking records related to the leukemia drug Treanda. A spokeswoman for the U.S. Attorney's Office in Manhattan said the office did not comment on cases unless charges were filed. A Cephalon spokeswoman declined comment.

Your editorial about the drug Provigil ("FTC remedy has side effects," Sunday) was distressingly weak on the facts and clearly wrong on policy grounds. You mention that a number of consumers, health plans, and other purchasers have filed class actions against Cephalon and the four generic-drug makers that originally made deals with Cephalon. But you don't discuss the specifics of the allegation: conspiring to restrain trade and prevent competition from lower-cost generic versions of Provigil, in violation of the antitrust laws.

Every day, Dawn Freney looks at her six children with fresh gratitude, amazed to think each of them protected her while growing in her womb. It's a logical thought. Last spring, the busy West Chester volleyball mom was diagnosed with multiple sclerosis. Her neurologists, who estimated she's had the crippling disorder for at least nine years, marveled at her vigor, considering she'd had no MS treatment. What she did have, one after another, were babies. And pregnancy is a time when women with MS usually get a reprieve from the intermittent immune-cell attacks that damage the nervous system.

Teva Pharmaceutical Industries Ltd., an Israeli company with North American headquarters in North Wales, agreed to pay $7.46 billion for rival generic-drug maker Barr Pharmaceuticals Inc., the two companies said yesterday. Teva, which employs 1,500 at four locations in the Philadelphia suburbs, said the deal would expand its already leading share of the generic pharmaceutical market in the United States and strengthen its presence in key Eastern European markets. The deal is an "unparalleled combination of people and products," William S. Marth, president and chief executive officer of Teva North America, said in an interview.

LONDON - Shares in pharmaceutical company AstraZeneca PLC soared today on news that an agreement with an Indian company will delay the release of a generic competitor to its best selling heartburn drug for six years. AstraZeneca said financial guidance for 2008 would remain unchanged, but the company's shares shot up almost 9 percent as analysts sensed less of a profit risk for the London-based drug maker. India's Ranbaxy Laboratories Ltd. had submitted an application to the U.S. Food and Drug Administration to make a generic version of esomeprazole magnesium, the active pharmaceutical ingredient in heartburn medicine Nexium.

ACCESS to affordable prescription drugs is an issue that is increasingly plaguing seniors and working families. As a result, Wal-Mart has made 331 generic prescriptions available to customers for only $4 a prescription for up to a 30-day supply at commonly prescribed dosages. The program is now available at all 3,810 Wal-Mart and Sam's Club pharmacies, including 141 in Pennsylvania. Certain restrictions apply in Pennsylvania due to state laws, but 275 generic drugs are still available for $4, while 56 others will be offered for just $9 per prescription.