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Strategies & Market Trends : Bosco & Crossy's stock picks,talk area -- Ignore unavailable to you. Want to Upgrade?

To: Crossy who wrote (3425)	6/13/2003 2:57:14 AM
From: Steve Misic	Read Replies (1) \| Respond to of 37387

Crossy, I'm sure you saw this. Rules May Speed Generics to Market FDA and Congress Aim to Counter Escalating Prescription-Drug Prices By LEILA ABBOUD Staff Reporter of THE WALL STREET JOURNAL WASHINGTON -- The Bush administration and Congress are taking steps to speed generic drugs to market to curb escalating prescription-drug costs. President Bush is expected to announce Thursday new Food and Drug Administration rules designed to close loopholes that manufacturers of brand-name drugs use to delay generic competition. The FDA also will announce plans to beef up its Office of Generic Drugs, infusing it with cash and imposing performance goals to speed approvals. Meanwhile, the Senate Health, Education, Labor and Pensions Committee Wednesday passed a bill that would go even further than the FDA rules in reducing the brand-name companies' ability to use litigation and anticompetitive practices to stall consumer access to cheaper generic drugs. Taken together, the changes could save patients, insurance companies and others billions of dollars annually. The new FDA rules alone will save $3.5 billion a year, by the Bush administration's estimate. Although wrangling over the duration of patents has been the primary focus of the debate over generic drugs, the seemingly arcane regulatory changes at the FDA also could have a major impact on consumers' access to cheaper drugs. The agency hopes its initiative will shave the average time for generic drug approvals by three months or more. The Office of Generic Drugs has long struggled with a small staff and budget. But the Bush administration and FDA Commissioner Mark McClellan are trying to change that. They have asked for $13 million -- the largest infusion of cash ever to the program -- to hire 40 new generic-drug reviewers and improve efficiency in fiscal 2004. There is much room for improvement. It now takes an average of 20 months for a generic-drug approval, compared with 15 months for a standard new drug and six months for a priority drug. Since 93% of generic-drug applications fail on their first FDA review, the approval process stretches out, delaying consumers' access to generics by months or years. Generic-drug reviews aren't intrinsically time-consuming, as they are less complicated than new drug applications. Applicants must show that the generic is biologically equivalent to the original drug, in addition to standard information on manufacturing and labeling. But the reviews tend to be lengthy because FDA resources are scarce, applications vary in quality, and internal FDA policies discourage communication with drug companies. The disparities between the way the FDA handles new drug applications and generic applications are stark. The Office of New Drugs has 576 staffers working on applications; the office of generic drugs has 90. The 2002 budget for new drug reviews was $347.6 million, fueled by $161.8 million in user fees from drug companies. That same year, the Office of Generic Drugs got $39.3 million. While the FDA had 1,393 meetings with companies working on new drug applications last year, it had 12 with generics makers. Such meetings can facilitate smooth approval by giving drug makers the chance to ask the FDA what kinds of data it wants. On the new drug side, such meetings were mandated by Congress in 1992 when drug makers agreed to pay user fees to the FDA to speed approvals. While generic drug makers feel disadvantaged by the FDA's closed-door policy, they don't want to pay user fees. Another stumbling block: The FDA's internal policies discouraging communication between generic companies and drug reviewers. After major scandals in the early 1990s when a few generics companies bribed FDA officials and falsified application data, strict rules were put in place. Gary Yingling, a lawyer for generics companies, said he was told to stop his frequent visits and barred from writing thank-you notes to reviewers. The FDA is now promising to conduct early communications with generic-drug makers and begin regular meetings with the generic drug trade associations. But that could cause more problems for a short-staffed office. "Can they have their guys going to the meetings and still reviewing things in 10 months?" asked Mr. Yingling. The Pharmaceutical Research and Manufacturers of America, a drug-industry trade group, didn't oppose the FDA rules to be announced by President Bush Thursday. But it opposes the Senate bill. Alan Holmer, the group's president, said in a statement that the industry group believes the current law "works well for patients and that further legislation is unnecessary." ***** Limited Shelf Life Major drugs that have gone or will soon go off patent, and their world-wide sales DRUG NAME/MAKER PATENT EXPIRATION 2001 SALES (millions) Off patent Axid/Eli Lilly April 2002 $285 Claritin/Schering-Plough December $3,159 Augmentin/GlaxoSmithKline December $2,046 Intron A/Schering-Plough December $1,447 Relafen/GlaxoSmithKline December Not available Singulair/Merck February 2003 $1,375 To go off patent this year Cipro/Bayer November 2003 $1,758 Flovent/GlaxoSmithKline November $1,317 Flonase/GlaxoSmithKline November $726 Energix-B/GlaxoSmithKline December $641 Source: Generics Pharmaceutical Association online.wsj.com.