Recently in Generic Drugs News Category

WASHINGTON -- The Bush administration yesterday proposed about a $100 million increase in the Food and Drug Administration's budget for fiscal 2008 that includes the first user fee for the generic drug industry as well a big boost in fees paid by brand-name pharmaceutical companies.

The FDA said the budget increase will be devoted to improving the screening and safety of new drugs; stepped-up oversight of medical devices; strengthening of food safety in light of recent food- borne outbreaks; and more timely reviews and approvals of lower-cost generic drugs.

The President's blueprint calls for $2.1 billion in overall FDA spending during fiscal 2008, up from a projected $2 billion for the current fiscal year.

All leading medical journals use independent experts, known as 'peer reviewers,' to decide whether research submitted to the journals is of good quality and worthy of publication. Journal editors know that some people are better at the job of peer-reviewing than others but it is hard to predict who will make a good reviewer.

n a recent survey, experienced reviewers were asked about training they had received in peer review and about other aspects of their background. The results, published in the latest issue of PLoS Medicine, show there are no easily identifiable types of formal training and experience that predict reviewer performance. The implications of these findings are discussed by the PLoS Medicine editors in an editorial to be published in the same issue.

source - Medical News Today

Drug companies increasingly are reaching legal settlements that delay the introduction of cheaper generic medicines and cheat Americans of billions of dollars in savings, regulators on Wednesday told lawmakers seeking to ban the agreements.

The Federal Trade Commission and others allege the settlements allow brand-name pharmaceutical companies to pay off would-be generic competitors, which then agree to delay introduction of their less costly but otherwise identical versions of the original medicines.

The FTC issued a report Wednesday, to coincide with a Senate Judiciary Committee hearing on the topic, that shows the settlements have become more common since two 2005 appeals court decisions upheld their legality.

Jan. 11 (Bloomberg) -- Barr Pharmaceuticals Inc., the second-largest U.S. maker of generic drugs, is lobbying for a U.S. law that for the first time would routinely allow the sale of copies of medicines made from biotechnology.

"It's what we're eating and breathing," said Jake Hansen, Barr's chief lobbyist in Washington. The company is dispatching about a dozen representatives to press Congress for the law, along with lobbyists from other generic-drug makers. "It's definitely our main focus."

The biotech industry, which includes companies such as Amgen Inc. and Genentech Inc., is countering with its own lobbying campaign. The biotech drugmakers say making copies of gene-based medications, which are more complex than traditional treatments, could pose health risks.

DARMSTADT, Germany (AFX) - Merck KGaA is considering selling its generics drugs business to focus on new medication, according to a report in Handelsblatt newspaper, citing sources.

Merck (nyse: MRK )'s generics unit could be worth around 4 bln eur, added the report.

The company's supervisory board has already given 'the green light' to look for a buyer, the report stated, citing sources.

SHANGHAI, China-A Chinese court has upheld the validity of drug maker Pfizer Inc.'s patent for Viagra, ordering two companies to stop sales of generic versions of the erectile dysfunction treatment and pay compensation for trademark infringements, a court official said Thursday.

The Beijing No. 1 Intermediate People's Court ordered Beijing Health New Concept Pharmacy Co. to stop sales of blue pills similar to Viagra, according to a court official who gave only his surname, Wang.

U.S. regulators cleared six more companies to begin selling generic copies of Merck & Co.'s cholesterol drug Zocor, signaling steeper price reductions.

The approvals posted on the Food and Drug Administration's Web site Wednesday are in addition to those granted Teva Pharmaceutical Industries Ltd. and Ranbaxy Laboratories Ltd. in June when Merck's patents expired. The new versions of the world's second-best-selling cholesterol-lowering pill will drive prices down as much as 70 percent, analysts said. Teva has been selling copies for 8 percent less than Merck.

The price drop may hurt sales of Pfizer Inc.'s Lipitor, the world's top-selling drug, with revenue last year of $12.2 billion, and the source of almost half of the New York-based drugmaker's profits. Lipitor prescriptions declined 6 percent in the fourth quarter as health plans encouraged patients to switch to generic copies of Zocor, Bear Stearns analyst John Boris said in a Dec. 21 research report.

HealthDay News -- The U.S. Food and Drug Administration has approved a generic version of Merck & Co.'s Proscar (finasteride). The drug is used to treat symptomatic benign prostatic hyperplasia (BPH), the medical term for an enlarged prostate.

More than half of men in their 60s and as many as 90 percent in their 70s and 80s have some symptoms of BPH, the U.S. National Institutes of Health says.

Approval to produce a 5 mg. generic version of finasteride was granted to Mylan Laboratories Inc., the Pittsburgh-based company said Tuesday.

In the year ending Sept. 30, total U.S. sales of finasteride 5 mg. tablets were $553 million, Mylan said.

WASHINGTON -- Biotechnology lobbyists attempting to slow the development of cheap generic versions of the world's most expensive drugs have been emphasizing questions about their safety in an effort to win support among the new Democratic leaders of Congress.

James C. Greenwood , a former congressman who is president of the Biotechnology Industry Organization , began raising qualms about drug safety with former colleagues on Capitol Hill even as the lawmakers were enlisting cosponsors for legislation to create a speedy mechanism for so-called biogenerics to reach the market.

"We think safety needs to be the primary concern. We think that in order to assure safety, you have to bring a full complement of data with the follow-on product," Greenwood told the Globe in a recent interview.

by Shankar Vedantam

Treating schizophrenia with an older, cheaper drug, rather than with heavily promoted newer medications, reduces the cost by as much as 30 percent with no apparent difference in safety and effectiveness, according to the first study to examine the economic implications of antipsychotic drug prescribing practices in the United States.

The newer drugs, such as Zyprexa, Seroquel and Risperdal, have cornered the lucrative U.S. market for antipsychotic drugs at a cost of $10 billion a year -- or around $100 for every family.

The findings have roiled the field of psychiatry in a fierce debate over the study's implications and have triggered concerns it could lead public and private insurers to limit drastically which drugs they will pay for.