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Generic Drug

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BUSINESS
January 24, 1993 | By Marian Uhlman, INQUIRER STAFF WRITER
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.
NEWS
October 30, 2001
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?
BUSINESS
September 22, 2012 | By Anna Edney, Bloomberg News
A $300 million program to speed U.S. reviews of generic drugs made by Mylan Inc., Teva Pharmaceutical Industries Ltd. and other companies may not start as planned on Oct. 1 because of a budget impasse in Congress. The industry's deal with the Food and Drug Administration to pay user fees for the first time was to mimic long-standing arrangements for brand-name drugs and medical devices. The snag for generics is that because their program is new, lawmakers must pass legislation authorizing the FDA to collect the money, Donald Beers, associate chief counsel for drugs at the agency, said at a meeting in Silver Spring, Md. Friday.
NEWS
December 6, 1989 | By Lini S. Kadaba, Inquirer Staff Writer
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.
BUSINESS
January 17, 1991 | By Donna Shaw, Inquirer Staff Writer
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.
BUSINESS
August 27, 1989 | By Marian Uhlman, Inquirer Staff Writer
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...
BUSINESS
September 12, 1989 | By Marian Uhlman, Inquirer Staff Writer
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.
BUSINESS
March 7, 2013 | By David Sell, Inquirer Staff Writer
Generic drugs have dramatically changed the pharmaceutical and health-care landscape in the last 25 years and now account for about 80 percent of prescriptions in the United States, with lower prices for consumers and insurers. But a U.S. Supreme Court case scheduled for argument March 25 pits drug companies, generic and branded, against government officials who argue that prices for consumers would be even lower if those companies did not strike deals to restrain trade. Drugstore chains and health insurers back the government's side.
BUSINESS
May 25, 2012 | By David Sell and INQUIRER STAFF WRITER
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.
NEWS
December 20, 1990 | By David Hess, Inquirer Washington Bureau
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.
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ARTICLES BY DATE
BUSINESS
May 20, 2015 | By David Sell, Inquirer Staff Writer
Endo Pharmaceutical P.L.C. said Monday that it will pay $8.05 billion for privately held Par Pharmaceutical Holdings L.L.C., to strengthen its position on the shifting landscape of generic drugmakers. The stock-and-cash sale comes amid consolidation in the market for generic drugs, as companies strive for greater leverage and profit, while patients and payers complain of rising prices. Some of the large generic drugmakers also sell so-called branded drugs, which usually carry higher prices because they are protected from market competition by patents.
NEWS
November 21, 2014 | By David Sell, Inquirer Staff Writer
The 1984 federal law that spawned the generic pharmaceutical industry was designed to use the basic idea of economic competition to lower the cost of prescription medicine for millions of Americans. The law has largely served its intended purpose. The Centers for Medicare and Medicaid Services said in January that the national rate of retail prescription drug spending slowed in 2012, growing only 0.4 percent because of "numerous drugs losing patent protection, leading to increased sales of lower-cost generics.
NEWS
March 13, 2014 | BY STEPHANIE FARR, Daily News Staff Writer farrs@phillynews.com, 215-854-4225
BELIEVING HE was a prophet with supernatural powers on a mission from God to conquer evil in Philadelphia, a Virginia Beach police officer stabbed two firefighters he thought were demons trying to stop his crusade, according to a lawsuit filed recently in Illinois federal court. Bradley Colas, the officer who filed the lawsuit, said that a generic form of the antibiotic Biaxin, which he was prescribed to treat bronchitis, caused him to experience an intense psychotic episode on March 4, 2012.
BUSINESS
January 4, 2014 | By David Sell, Inquirer Staff Writer
Two Israeli publications reported Thursday that Erez Vigodman will be named the new chief executive officer of Teva Pharmaceutical Industries Ltd., which has searched for a leader since Jeremy Levin departed in October after disagreements with the board of directors over how to operate the drugmaker. A member of the Teva board, Vigodman is CEO of Israel-based Makhteshim Agan Industries, which bills itself as the world's leader in "branded off-patent crop protection solutions. " Teva, which leads the world in generic-drug revenue, has headquarters near Tel Aviv.
BUSINESS
September 12, 2013 | By David Sell, Inquirer Staff Writer
GlaxoSmithKline P.L.C.'s top-selling drug by far is the asthma medication Advair, which accounts for about 20 percent of company revenue, but generic competition got a bit closer to reality this week. Advair is delivered to patients through an inhaler. Besides any existing patents, brand-name drug companies like Glaxo have hoped that the combination of a drug and a device would delay Food and Drug Administration issuance of guidelines for generic manufacturers who hope to make equivalent products.
BUSINESS
June 26, 2013 | By David Sell, Inquirer Staff Writer
In a case involving a Philadelphia company, a divided U.S. Supreme Court ruled Monday that federal pharmaceutical laws preempt a person's ability to sue in state court alleging that a generic drug is designed badly and therefore is dangerous. The court's 5-4 decision in Mutual Pharmaceutical Co. v. Bartlett is a victory for the drug industry and, indirectly, the U.S. Food and Drug Administration. A New Hampshire woman, Karen Bartlett, suffered severe skin reactions and is nearly blind after using a generic drug made by Mutual.
NEWS
May 10, 2013 | By Linda A. Johnson, Associated Press
TRENTON - Spending on prescription medicines in the United States fell for the first time in decades last year, slipping as cash-strapped consumers continued to cut back on use of health-care services. Patients also benefited from a surge of new, inexpensive generic versions of widely used drugs for chronic conditions such as high cholesterol, according to a new report. Total spending on medications dipped 1 percent, to $325.8 billion last year from $329.2 billion in 2011. Likewise, average spending per person on medicines fell by $33, to $898 last year, according to the report from the IMS Institute for Healthcare Informatics.
BUSINESS
March 25, 2013 | By David Sell, Inquirer Staff Writer
The U.S. Supreme Court will hear arguments Monday in a case that affects the health and wallets of millions of Americans, most of whom know nothing about the contentious issue. Brand-name and generic pharmaceutical companies are usually competitors. But brand-name companies are increasingly paying generic companies to stay out of the market, delaying the availability of cheaper medicine. "This matters because drug prices are important to all of us," said Rutgers-Camden law professor Michael Carrier, who co-wrote a friend-of-the-court brief for the case, Federal Trade Commission v. Watson Pharmaceuticals, et al . Carrier wrote on behalf of 117 other law and business professors, and he is one of several Philadelphia-area elements in this legal landscape.
BUSINESS
March 21, 2013 | By David Sell, Inquirer Staff Writer
WASHINGTON - Supreme Court justices questioned and debated Tuesday the proper reach and power of federal law in the regulation of generic drugs and whether a Philadelphia company is liable for $21 million in damages for horrific injuries suffered by a New Hampshire woman who took one of the company's medications. Mutual Pharmaceuticals Co. asked the justices to overturn a jury decision in favor of Karen Bartlett, 53, who had a rare reaction to the painkiller sulindac, in which her skin essentially peeled away and she was left nearly blind.
BUSINESS
March 20, 2013 | By David Sell, Inquirer Staff Writer
There is no debate that Karen Bartlett had a horrible reaction in 2004 to the drug sulindac, a generic painkiller made by Philadelphia's Mutual Pharmaceuticals Inc. About 60 percent of the New Hampshire woman's skin peeled away - necessitating months in a medically induced coma in a hospital burn unit - and she is mostly blind after 13 eye operations. There will be a debate Tuesday in the U.S. Supreme Court over whether federal regulations on generic drugs trump Bartlett's ability to sue for compensation in state court.
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