Drug Makers

Even Clarence Thomas, the Supreme Court justice who wrote the majority opinion saying that makers of generic drugs don't have to warn patients about newly discovered dangers, agreed that the idea made little sense. How is it that the maker of a brand-name pharmaceutical has to provide information about potential side effects but the companies that produce identical drugs don't? If this is the price the public is expected to pay for cheaper drugs, it's far too high. In a 5-4 decision issued last week, the court rejected lawsuits by two women who suffered serious side effects from generic versions of a medication used for stomach ailments.

Abbott Laboratories said it will pay $1.6 billion to settle federal and state claims that it improperly marketed the neurological medication Depakote for off-label uses. Abbott will pay $800 million to resolve civil allegations split among federal and state governments, $700 million in criminal penalties and $100 million to states to resolve consumer protection matters, the Abbott Park, Ill., company said Monday. Abbott said in previous filings with the Securities and Exchange Commission that it had earmarked $1.5 billion for a potential settlement.

WASHINGTON — As the president and congressional leaders look for savings as part of a major debt deal, the pharmaceutical industry has stepped up its behind-the-scenes lobbying to kill proposals that it contribute to any compromise. President Obama this spring said drug makers should offer discounts to low-income seniors who receive government subsidized health coverage through both the Medicare and Medicaid programs. And with pressure growing to cut federal support for state Medicaid programs and to force seniors on Medicare to pay more for their care, many liberal lawmakers are demanding that pharmaceutical companies chip in more, as well.

Amgen Inc. agreed to buy closely held Mustafa Nevzat Pharmaceuticals for almost $700 million to expand in Turkey, where economic growth is boosting demand for medicines. Amgen will pay cash to get 95.6% of Mustafa Nevzat, or MN Pharmaceuticals as the Istanbul generic-drug maker is known, the companies said Wednesday. The transaction will boost Amgen's presence in a region that has "large, fast-growing, priority markets," they said. Amgen is seeking to shore up revenue as its former core anemia franchise declines.

Reporting from Chicago After decades of research and multiple failed attempts to find a treatment, the pharmaceutical industry is entering a crucial phase in the search for a drug that can slow, or stop, the progression of Alzheimer's disease. Drug makers see huge moneymaking potential because of the aging population. Alzheimer's afflicts more than 5 million Americans and is one of the leading causes of death in the United States, according to the Centers for Disease Control and Prevention.

U.S. drug makers agreed Saturday to shell out $80 billion over the next 10 years to lower the cost of medication for seniors and help pay for President Obama's proposed healthcare overhaul, as part of an agreement hashed out with lawmakers and administration officials. The deal means the pharmaceutical companies will extend discounts on prescription drugs to millions of seniors who often must pay staggering drug costs not covered by their Medicare plan, according to a White House announcement.

The Food and Drug Administration is calling on pharmaceutical firms to give more attention to the potential for abuse of new drugs when subjecting them to pre-market testing. The agency this week released a draft of voluntary guidelines to assist drug makers in figuring out which compounds should be placed under the Controlled Substances Act. The law regulates the handling, record-keeping and dispensing of drugs deemed to be dangerous or addictive if misused -- in some cases imposing criminal penalties for misuse.

For the makers of brand-name prescription drugs, generic competition is about as welcome as a virus. In the first year that a generic competitor goes on the market, a brand-name drug loses on average more than half of its market share, and its price drops with each new generic company that produces a copycat, May 2005 study said. So companies that are about to face that competition have big incentives to delay the entry of new generics to the market -- and to erect obstacles to switching to the cheaper upstarts.

Rep. Henry A. Waxman (D-Los Angeles) opened an investigation of research and marketing related to medical devices and drugs made by Boston Scientific Corp., Johnson & Johnson, Eli Lilly & Co., AstraZeneca and Cephalon Inc. The companies received letters from Waxman, chairman of the House Oversight and Government Reform Committee, asking for documents including correspondence with the Food and Drug Administration.

Re "Memos shed light on drug lawsuit dispute," Oct. 30, and "High court looks split on suits against drug makers," Nov. 4 Your article provides support for why injured consumers must be allowed to bring lawsuits against drug companies that market unsafe drugs. The documents described in the article show top career FDA officials internally expressing strong concern about the agency's rules immunizing drug companies from liability. This is an unprecedented policy advocated by the current White House, and the U.S. Supreme Court is now considering its legitimacy.

For millions of Americans, prescription drugs are about to get a lot cheaper. Patents on some of the most popular medications will expire over the next few years, giving consumers access to less expensive generic versions — and costing the pharmaceutical industry an estimated $100 billion in lost sales through 2015. Lipitor, a cholesterol-fighting medication that is the top-selling prescription drug of all time, lost its patent protection Wednesday. The drug's manufacturer, Pfizer Inc., already has slashed its price to as little as $4 a month for privately insured patients, the majority of Lipitor users.

Prescription drugs and medical devices are frequently used to treat conditions other than those the Food and Drug Administration has specifically approved them for. The main guidance the FDA gives to doctors is to be well informed, have good scientific and medical reasons, and maintain records of any off-label use. The agency bars drug and device manufacturers, however, from promoting their products for more than their approved uses — for example,...

President Obama is pushing federal regulators to do more to address dangerous shortages of crucial medicines, sidestepping a deadlocked Congress that has not dealt with the problem. In an executive order signed Monday, the president directed the Food and Drug Administration to press drug companies to more quickly report shortages to federal regulators, an early warning that advocates say can help mitigate shortages. The order, which administration officials concede does not give the FDA any new authority, also told the agency to expedite reviews of new manufacturing facilities.

WASHINGTON — As the president and congressional leaders look for savings as part of a major debt deal, the pharmaceutical industry has stepped up its behind-the-scenes lobbying to kill proposals that it contribute to any compromise. President Obama this spring said drug makers should offer discounts to low-income seniors who receive government subsidized health coverage through both the Medicare and Medicaid programs. And with pressure growing to cut federal support for state Medicaid programs and to force seniors on Medicare to pay more for their care, many liberal lawmakers are demanding that pharmaceutical companies chip in more, as well.

Even Clarence Thomas, the Supreme Court justice who wrote the majority opinion saying that makers of generic drugs don't have to warn patients about newly discovered dangers, agreed that the idea made little sense. How is it that the maker of a brand-name pharmaceutical has to provide information about potential side effects but the companies that produce identical drugs don't? If this is the price the public is expected to pay for cheaper drugs, it's far too high. In a 5-4 decision issued last week, the court rejected lawsuits by two women who suffered serious side effects from generic versions of a medication used for stomach ailments.

Hats off to N.Y. Re "N.Y. legalizes gay marriage," June 25 It's bittersweet, but mainly sweet, seeing the great state of New York post a milestone in human rights. It's bitter in that my state, California, should have and could have been the first among the big states to do it instead of succumbing to the idiotic bigotry of Propositions 22 and 8. Poor California, which used to be the vanguard in so many ways, has been reduced to the vanguard of budget crises and little else.

U.S. officials issued final guidelines warning drug makers that some marketing practices, including gifts or payments to doctors, may run afoul of anti-kickback laws. Two "suspect" practices identified by the voluntary guidelines are payments from a company to physicians or pharmacists to switch patients to the manufacturer's drug and payments to doctors to listen to a pitch from a drug company representative.

The Supreme Court heads into the last two weeks of its term Monday, facing a final round of decisions on matters as varied as violent video games, global warming, drug prescription records and alleged gender bias at Wal-Mart stores. In all, the justices are due to hand down decisions in 14 cases that have been argued since November. They will meet Monday and Thursday of this week to announce opinions. The remaining cases are set to be decided the following week. Here are the major cases pending: •Video games: The court will decide whether California and other states can limit the sale of ultra-violent video games to minors.

Watson Pharmaceuticals Inc. has acquired privately held generic drug developer Specifar Pharmaceuticals for $562 million in cash to expand its presence in Europe. The deal for the Greek company broadens Watson's generic drug sales in Europe after the Corona company established a foothold in the region with its 2009 acquisition of Arrow Group. "It provides us with additional commercial capacity for our European businesses," Watson Chief Executive Paul Bisaro said. "We got the beachhead established, but now we needed the firepower to go out and expand that beachhead, and that's what this does.