LATELINES

High court to review FDA oversight of compounding

The Supreme Court will hear a case that struck down provisions of the 1997 FDA reform law that gave the agency a clear role in regulating some aspects of pharmacy compounding. Compounders were pleased by last February's federal appeals court decision that rejected the FDA's attempts to restrict advertisements about compounding services. The FDA had argued that if the advertising restrictions were found unconstitutional, then the entire compounding section should be scrapped. The court agreed.

HHS, Bayer reach a deal on Cipro

After a threat from HHS secretary Tommy Thompson to "bust" its patent, the Bayer Corp. agreed to sell the federal government 100 million tablets of Cipro (ciprofloxacin) for its emergency stockpiles at the reduced rate of 95 cents apiece. Bayer also gave the government two million tablets of the now widely known antibiotic approved for treatment of inhalation anthrax. Canada threatened to override Bayer's patent, too, but it backed down after the company said it would deliver 100 million tablets to the government within 48 hours of a request.

The U.S. deal gives HHS the option of ordering another 100 million tablets at 85 cents each, with additional orders at 75 cents per tablet. HHS said the government usually pays $1.77 a tablet for Cipro, but some federally funded clinics can get it for about one-fourth as much. AWP is $4.67. Bayer has increased U.S. production from 20 million tablets a month to more than 200 million over the next three months in the wake of the bioterrorism incidents that followed the Sept. 11 airline hijacking attacks on the World Trade Center and the Pentagon.

Consumer groups sue Bayer, Barr over Cipro deal

A legal team representing consumer groups in 11 states has sued Bayer Corp. and three other Rx makers over a patent settlement they charge is keeping generic Cipro (ciprofloxacin) off the market. The Prescription Access Litigation project said Bayer has paid Barr Laboratories, Rugby, and Hoechst-Marion Roussel a total of $200 million to give up their legal challenges to Bayer's patent on Cipro, which expires in December 2003. Barr said the settlement is pro-consumer since it allows production of a generic six months before expiry.

Drugmakers join war effort, too

Johnson & Johnson is submitting data to the FDA to allow it to add anthrax as an indication for Levaquin (levofloxacin). If the indication is approved, Johnson & Johnson said it would donate up to 100 million tablets to the federal government. Bristol-Myers Squibb also is seeking an anthrax indication for Tequin (gatifloxacin) and said it would provide the Rx free to anyone exposed.

Pfizer is increasing production of Vibramycin (doxycycline), which is indicated for cutaneous and inhalation anthrax. At least five generic firms also make doxycycline tablets or capsules. Pfizer is the sole supplier of doxycycline syrup and powder.

PhRMA has formed a Task Force on Emergency Preparedness and said its members have pledged to offer free antibiotics for persons infected or exposed to anthrax, develop and manufacture a smallpox vaccine, give government scientists access to company laboratories and production facilities, and make company scientists available to work in government facilities as needed.

Bush's Rx discount card plan back in court

HHS has asked a federal court to stay a preliminary injunction it imposed against the Bush Administration's proposal for a Medicare-endorsed prescription discount card program to be offered by PBMs. In a motion before U.S. District Court Judge Paul Friedman, HHS said it wanted to solicit public comments and indicated it might make changes in the proposal. NCPA and NACDS, whose joint suit halted the administration's plan, quickly filed a reply that noted the judge already ruled the pharmacy groups had a "very high" likelihood in prevailing in their original claim that the administration lacked the legal authority to establish a discount card program.

Eon Labs donates antibiotic

In the midst of the anthrax scare, Eon Labs has donated doxycycline to the New York State department of health. The New York City-based generic drug company is providing 100,000 capsules of 100-mg-strength doxycycline monohydrate, an antibiotic indicated for anthrax treatment. The donation was made in response to state queries about the firm's current doxycycline inventory and manufacturing capacity.

House panel not impressed by Rx discount card

Several members of the House Small Business Committee reacted skeptically to the Bush Administration's proposed Medicare Rx discount card program at a hearing Oct. 25. Committee chairman Don Manzullo (R, Ill.) suggested his state's direct pharmaceutical assistance program that reimbursed at AWP minus 10% plus a variable dispensing fee was better for seniors and pharmacies. Rep. Lydia Velazquez (D, N.Y.) registered her opposition. Gary Sims, a co-owner of four Drug Emporium stores in West Virginia, called that state's discount card program a "pharmacy tax." In his stores, seniors saved an average of 10.4% per Rx, while his gross profits on them fell 37%.

Celebrex gains new indication

Pharmacia and Pfizer's Celebrex (celecoxib capsules) has just been approved for treating acute pain and menstrual pain. The recommended dose for acute and menstrual pain is 400 mg initially, followed by a 200-mg dose if needed on the first day. On subsequent days, the recommended dose is 200 mg twice daily as needed. With this new indication approval, Celebrex has the broadest range of approved indications of any COX-2 inhibitor, claim the two companies. Celebrex is also approved for relieving the pain associated with osteoarthritis and rheumatoid arthritis and for reducing the number of adenomatous colorectal polyps in familial adenomatous polyposis.

PPI fast-tracked for rare disease

Zollinger-Ellison syndrome (ZES) patients who can't take oral medications can now resort to Protonix IV (pantoprazole sodium) for Injection from American Home Products. Protonix IV was first approved this past March for short-term treatment of GERD. Now the proton pump inhibitor (PPI) can also be used to provide quick acid suppression, which can save the lives of ZES patients. A chronic and rare disease, ZES is often associated with tumors of the pancreas and gastroduodenal ulcers. AHP claims Protonix IV is the first and only IV PPI for ZES in this country. The drug was approved by FDA on a priority-review basis.

New anti-HIV drug offers convenient dosing

Gilead Sciences' Viread (tenofovir disoproxil fumarate) has been cleared to treat HIV infection when used with other antiretroviral agents. The Foster City, Calif., firm claims the product is the first nucleotide analog reverse transcriptase inhibitor to be approved for this indication. Nucleotides last longer than other anti-HIV drugs in cells, allowing for Viread to be dosed as a 300-mg tablet once daily with food. In studies, the drug reduced the level of HIV in patients for up to 48 weeks when given with other antiretrovirals.

DEA, health groups come together on pain policy

DEA and 21 healthcare groups have signed a consensus statement designed to protect the appropriate use of opioid pain relievers for patients who need them, while preventing the abuse and diversion of the powerful drugs. The statement includes recognition that "undertreatment of pain is a serious problem." APhA was among the signatories, and president Tom Menighan said at a news conference that the collaborative effort helped DEA better understand that there are pharmacies that specialize in pain management where seemingly abnormal amounts of opioids are dispensed.

Home anthrax tests slated to debut

As the anthrax scare spreads across the country, at least two firms are rushing out OTC home anthrax tests. Vital Living Products, Matthews, N.C., is getting set to launch PurTest Anthrax Home Test, which can detect anthrax bacteria in the air, on mail, or in water. Donald Podrebarac, president/CEO of Vital Living Products, told Drug Topics that Ace Hardware has already assigned product codes to the product, which will retail for between $19 and $25. The test is designed to give results within 24 to 48 hours. Professional Labs, based in Florida, expects its anthrax test to hit the market before the end of the year. But buyers should beware. Anthrax kits aren't tested or approved by any government agency.

Hospital R.Ph. indicted in fatal error

An Ohio hospital pharmacist was indicted on a criminal charge stemming from the overdose death of a cancer patient at Riverside Mercy Hospital outpatient pharmacy in Toledo in July 2000. The pharmacist was charged with one count of involuntary manslaughter for dispensing Adriamycin and vincristine doses via an infusion pump for four days instead of one dose spread out over four days. The tentative trial date is Dec. 4. If convicted, he could be sentenced to up to five years in prison. He was fined $1,500 for unprofessional conduct by the pharmacy board in August.

Many R.Ph.s work multiple jobs in N.Y.

Pharmacists are fetching an annual median income of $72,400 in New York. But, in addition to their primary position, many pharmacists work multiple jobs, pulling in $10,000 on average from these sidelines. Those are some conclusions of a survey of 18,000 R.Ph.s in the state. Conducted by the New York State Board of Pharmacy, the 38-question survey drew a response rate of 52%. Full results will be posted shortly on the board's Web site, revealed David Schaff, Pharm.D., chairman of the board, at a recent legal seminar sponsored by the Arnold & Marie Schwartz College of Pharmacy & Health Sciences in New York.

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Drug Topics

2001;21:7.