Generic Drug

The Sun article regarding the U.S. Supreme Court and the pharmaceutical industry ("Drug industry tallies 2 high-court victories," June 24), reports how a decision of the court is "shielding the makers of generic drugs from most lawsuits filed by injured patients. " Something is wrong when the incomplete copy of a patented drug is treated better than the original. A patient injured by a generic drug needs some avenue for corrective action. Suing the manufacturer should at least be a patient's last recourse.

When Gail Folena-Wasserman joined Gaithersburg biotechnology startup MedImmune in 1991, she was its first employee in research and development, and dreamed of what the company might be "when it grew up. " Two decades later, the senior vice president for biopharmaceutical development is helping to test new drugs at a dramatically different MedImmune. Five years since a $15 billion acquisition by British pharmaceutical giant AstraZeneca, the company is funneling a pipeline of potential therapies that has grown three times over and covers a wider spectrum of diseases.

In its recent decision on drug labeling, the U.S. Supreme Court prescribed a judgment that looks like bad medicine. The court ruled in Pliva v. Mensing that the Food and Drug Administration's regulatory system pre-empts any claim in a state court that the maker of a generic drug did not adequately warn consumers of potential risks from the product. Two years ago, in Wyeth v. Levine, the court looked at a similar case but took a different approach, holding manufacturers of federally approved brand-name drugs liable for inadequate labeling.

In its recent decision on drug labeling, the U.S. Supreme Court prescribed a judgment that looks like bad medicine. The court ruled in Pliva v. Mensing that the Food and Drug Administration's regulatory system pre-empts any claim in a state court that the maker of a generic drug did not adequately warn consumers of potential risks from the product. Two years ago, in Wyeth v. Levine, the court looked at a similar case but took a different approach, holding manufacturers of federally approved brand-name drugs liable for inadequate labeling.

At least one generic drug can be used effectively to control epilepsy and other seizure disorders -- and save patients hundreds of dollars -- despite a widespread belief among neurology specialists that generics don't work as well as the more expensive brand-name medications.Researchers at the Bowman-Gray School of Medicine in Winston-Salem, N.C., found that Epitol, a generic version of the seizure-control drug carbamazepine, works as well as the heavily prescribed brand-name version, Tegretol.

A federal judge yesterday sentenced the former head of a drug company to five years in jail and a $1.25 million fine -- the largest penalty against an individual since the government began investigating generic drug fraud four years ago.Judge John R. Hargrove imposed the sentence upon Robert Shulman, 59, of Centerport, N.Y., for filing false statements to gain approval for products made by Bolar Pharmaceutical Inc. of Copiague, N.Y.The sentence, handed down...

A federal grand jury this week charged five former officials of a Brooklyn, N.Y., firm with selling generic drugs that had not been approved by the U.S. Food and Drug Administration.The six-count indictment in U.S. District Court in Baltimore charged that Jay Marcus, the former president of Halsey Drug Co. Inc., and four other former company executives conspired to obstruct regulation by the FDA.Company officials allegedly shipped adulterated and unapproved generic drug products interstate in violation of federal law. Other charges include filing false statements with the FDA and obstruction of inspection.

The former director of the U.S. Food and Drug Administration's generic drug division has been convicted of two perjury charges for lying to federal investigators about accepting lunches from officials of the industry his agency regulated.Dr. Marvin Seife, 66, of Houston, the division director for 18 years until he retired last December, is the highest-ranking FDA official to be convicted in a two-year investigation that has resulted in the convictions of more than a dozen former FDA officials, generic drug companies and company executives on corruption charges.

They look like ATMs but when the right password is punched in, prescription drugs - all generics - pop out instead of greenbacks. And soon these machines, which encourage doctors to prescribe generics instead of more expensive brand-name drugs, could be coming to a physician's office near you. The machines allow doctors to give patients their first prescription of a generic drug free, straight from the machines. Patients cannot access the machines without authorization. If the patient requires a refill, the doctor writes a regular prescription for the generic drug to be filled at the normal price at a drugstore.

A federal judge in Baltimore fined American Therapeutics Inc. of Bohemia, N.Y., $1 million today on racketeering, drug adulteration and obstruction-of-justice charges in two felony cases.First Assistant U.S. Attorney Gary P. Jordan told Judge John R. Hargrove that the large fine was "appropriate" because ATI's criminal acts were "extensive," ranging from bribery to product fraud as its former chief executive bought favors from U.S. Food and Drug Administration officials in an effort to stay ahead of competitors.

The Sun article regarding the U.S. Supreme Court and the pharmaceutical industry ("Drug industry tallies 2 high-court victories," June 24), reports how a decision of the court is "shielding the makers of generic drugs from most lawsuits filed by injured patients. " Something is wrong when the incomplete copy of a patented drug is treated better than the original. A patient injured by a generic drug needs some avenue for corrective action. Suing the manufacturer should at least be a patient's last recourse.

I have suffered with insomnia for years. My doctor prescribed Ambien, which gives me eight hours of restful sleep. Then the pharmacist switched me to generic zolpidem for under $15. He said it was identical to Ambien. It wasn't! I haven't had a decent night's sleep since switching. If I do fall asleep I have horrible nightmares. I cannot afford $130 for regular Ambien. What else can I do? I need my sleep to be alert at work. Dozens of other readers have also reported problems with generic Ambien (zolpidem)

It's a drag when you suffer from depression. And it's really a drag when the medication you've been treating your depression with effectively for years suddenly leaves you feeling anxious, nauseated or even suicidal. Even more of a drag? When you realize those symptoms began when you switched from your brand-name antidepressant to its generic version. But it's downright depressing when your doctor, pharmacist and health insurance provider insist that these side effects you're experiencing must be in your head.

WASHINGTON -- Marta Ockuly was a week away from gaining health insurance at her new job in Sarasota, Fla., when she was diagnosed with a devastating form of cancer. She quickly began chemotherapy, which drove her leukemia into remission but weakened her body's immune system so much that she required shots of a new kind of drug, made using biotechnology. Ockuly credits the biotech drug, Neupogen, with helping save her life four years ago, but wishes there had been a generic alternative available for less than the $1,000-a-shot she says hers cost.

They look like ATMs but when the right password is punched in, prescription drugs - all generics - pop out instead of greenbacks. And soon these machines, which encourage doctors to prescribe generics instead of more expensive brand-name drugs, could be coming to a physician's office near you. The machines allow doctors to give patients their first prescription of a generic drug free, straight from the machines. Patients cannot access the machines without authorization. If the patient requires a refill, the doctor writes a regular prescription for the generic drug to be filled at the normal price at a drugstore.

The Viagras and Zolofts, the Lipitors and Nexiums, are in trouble. Such blockbuster drugs have earned billions for their creators, but patents are soon to expire on some of the most popular products, opening their formulas to generic copycats and threatening future profits for drug companies desperate to produce the next generation of stars for the medicine cabinet. That situation underlies this week's announcement by Merck & Co. Inc. that it will lay off 7,000 employees, a 10th of its work force, and shutter five of 31 manufacturing sites to save $4 billion through 2010.

In a little-noticed move with broad implications for the $40 billion prescription drug industry, the Food and Drug Administration has started a debate on changing the way it approves generic versions of brand-name drugs.Under one proposal, the maker of a brand-name drug would have to tell the agency more than it now does about what goes into its product. The FDA would publish standards for the ingredients and for testing them.Years later, when a drug loses patent protection, other drug makers could refer to the publication, called a monograph, to speed FDA approval of a low-priced generic version.

As Mark Perkal stood before a judge yesterday to be sentenced in a generic drug scam, he did not stand alone. His family and members of Baltimore's Hasidic community stood with him.While seven witnesses, including his wife and daughter, testified that Perkal was a pillar of the community and a religious man with the highest moral values, 100 more supporters jammed Judge John R. Hargrove's U.S. District Courtroom and overflowed into the lobby.That outpouring of support apparently worked.Judge Hargrove sentenced Perkal, 46, of the 3800 block of Labyrinth Road, to four months of the least restrictive form of home detention on his guilty plea to charges of obstruction of justice and aiding and abetting false statements to the U.S. Food and Drug Administration.

WASHINGTON - Mabel Stoltz, at 93, lives independently in her own home in a quiet harbor town on the Minnesota shore of Lake Superior. But she has to watch her budget carefully and has been buying prescription drugs from Canada. So Stoltz was surprised to learn recently that she could buy her generic-label medications for much less from a U.S. pharmacy - a potential savings of $560 a year for two prescriptions. "I do have enough money to pay, but I don't know how long it will last at this rate," said Stoltz, who once worked as a medical secretary.

I had a terrible experience with a generic high blood pressure medication. For five years, I took Tenoretic. Both my doctor and I were pleased with the results. Then the pharmacist encouraged me to switch to atenolol, its generic counterpart. Two weeks later I had a routine dental appointment. My dentist would not clean my teeth because my blood pressure was dangerously high. He instructed me to go directly to my doctor. I switched back to Tenoretic, and my blood pressure went back to normal.