FDA'a latest bulletin

[Chris Ryser]

In Today's Bulletin ...........

OPHTHALMIC DEVICES PANEL TO VOTE ON TWO PMAs

The FDA's Ophthalmic Devices Panel will meet Feb. 5-6, 2004 at the Gaithersburg Marriott in Gaithersburg, Md.

On Feb. 5, the committee will discuss, make recommendations and vote on a premarket approval application for a phakic intraocular lens for the reduction or elimination of myopia in adults.

On Feb. 6, the committee will discuss, make recommendations and vote on a PMA for a radiofrequency electrosurgical corneal shaping device for the temporary treatment of presbyopia. From 8:30 a.m. to 9 a.m., the meeting will be closed to permit FDA staff to present trade secret or confidential commercial information relating to pending and future ophthalmic device submissions to the committee.

Submissions for oral or written contributions to the meeting must be made by Jan. 26.

To see the notice on the meeting, go to http://www.accessdata.fda.gov/script...s.cfm?mtg=443.

[Chris Ryser]

In Today's Bulletin.........................

LUPRON AWP SUIT MOVES TO CLASS CERTIFICATION PHASE
A class action lawsuit against TAP Pharmaceuticals and controlling partners Abbott Laboratories and Takeda Chemical, alleging the firms overcharged thousands of patients, will now move to the class certification phase.

Denying the firms' recent motion to dismiss the complaint, Judge Richard Stearns of the U.S. District Court District of Massachusetts found that the case built against the firms under the Racketeering Influenced and Corrupt Organizations Act (RICO) was sufficient to let the case continue. Stearns, however, dismissed claims that the racketeering extended to physicians who provided Lupron.

First filed May 2001, the suit is expected to move into the class certification phase sometime in 2004, plaintiffs' attorney Jeffrey Kodroff of Spector, Roseman & Kodroff said

[Chris Ryser]

In Today'S Bulletin .......................

FDA MAY REQUIRE PMA FOR THREE DEVICE TYPES

The FDA has issued a proposed rule to require a premarket approval application (PMA) or completion of a product development protocol for three Class III preamendment devices.

The devices affected by the proposal include the indwelling blood oxyhemoglobin concentration analyzer, the cardiopulmonary bypass pulsatile flow generators and the ocular plethysmograph. Comments on the proposed rule will be accepted through Feb. 17.

[Chris Ryser]

In Today's Bulletin .....................................

PFIZER DONATES BLINDNESS TREATMENT, IDA AWAITS ACTION ON HIV DRUG

While Pfizer plans to dramatically increase international drug contributions to eradicate preventable blindness, licensing partners for an HIV/AIDS drug still are waiting for the company to take the next step in a program brokered by subsidiary Pharmacia earlier this year.

According to an announcement at United Nations headquarters last week, Pfizer intends to donate 135 million doses of its antibiotic Zithromax (azithromycin) during the next five years to the International Trachoma Initiative it helped co-found five years ago in an effort to treat the estimated 150 million infected with the blinding disease. The disease is prevalent in 85 countries in Africa, Asia, and Central and South America.

While Pfizer's philanthropic efforts were lauded by many, what remains to be seen is the firm's stance on a nonexclusive licensing deal with the Dutch nonprofit International Dispensary Association (IDA) and the Thailand-based Concept Foundation for the antiretroviral drug Rescriptor (delavirdine). Prior to Pharmacia's merger with Pfizer in April, Pharmacia said it would grant nonexclusive licenses to the organizations to pass on to generic drugmakers that agreed to supply the HIV/AIDS drug to poor countries.

Despite reports claiming that the deal had failed, principals at IDA and the Concept Foundation said they "have not been informed by Pfizer on any decision concerning this project."

[Chris Ryser]

In Today's Bulletin .............................

FDA APPROVES AUTOFOCUS LENSES

Eyeonics has received FDA approval for its first U.S. product, the Crystalens, an accommodating intraocular lens that allows patients to focus automatically at all distances.

According to the company, Crystalens is implanted during cataract surgery and accommodates like the eye's natural lens, allowing for clear vision without additional aids. Standard intraocular lenses restore only distance vision, with many patients still requiring glasses or contact lens to make up for other deficiencies.






BAUSCH & LOMB, OASIS SETTLE PATENT SUIT
Bausch & Lomb has settled a patent infringement lawsuit it brought against Oasis Medical involving microkeratome blades used during LASIK refractive laser surgery procedures.

Under the terms of the settlement, Oasis acknowledged the validity and infringement on the patent and has agreed to stop manufacturing and selling the blades for Bausch & Lomb's Hansatome microkeratome. Further details were not provided.

[Chris Ryser]

In Today's Bulletin....................................

FTC OKs ALLERGAN-OCULEX MERGER

The FTC has given the go-ahead for eye-care drugmaker Allergan to complete its proposed acquisition of the private biotech development firm Oculex Pharmaceuticals.

Allergan said it expects the transaction to be finalized by the end of the month. The companies announced the $230 million all-cash acquisition agreement last month, saying that Oculex's biodegradable intraocular drug delivery technology offers a superior method for targeting drugs to the back of the eye for disorders such as age-related macular degeneration, diabetic retinopathy and macular edema. The biodegradable polymer used by Oculex also controls sustained release of the drugs.

Allergan expects possible FDA approval in late 2006 or 2007 for Oculex's lead investigational product, Posurdex, assuming that Phase III clinical trials slated to begin early next year are successful. Posurdex is an implant that delivers dexamethasone to the back of the eye to treat macular edema.




CONMED FILES ANTITRUST SUIT AGAINST JOHNSON & JOHNSON
Conmed has filed suit against Johnson & Johnson (J&J) and several of its subsidiaries, including Ethicon, for violation of federal and state antitrust laws.

The lawsuit claims that J&J engaged in illegal and anticompetitive conduct regarding sales of products used in endoscopic surgery, resulting in higher prices to consumers and the exclusion of competition. The suit accuses J&J of entering into exclusive contracts with hospitals requiring the hospitals to purchase endoscopy products only from J&J, tying and bundling the price of sutures to a hospital's agreement to buy a very high percentage of their endoscopy products from J&J, threatening and imposing financial penalties on hospitals if they purchased other endoscopy products, and giving hospitals inaccurate and misleading information as to their ability to deal with Conmed.

The suit also alleges that J&J furthered its anticompetitive conduct with contracts with group purchasing organizations such as Novation and Premier. Conmed is seeking an injunction restraining J&J from continuing anticompetitive practices and the maximum amount of damages allowed by the law.

[Chris Ryser]

In Today's Bulletin .................................................

ALLERGAN SUIT SAYS FDA, HHS ERRONEOUSLY RECLASSIFIED DRY EYE DRUG


Allergan is taking the FDA and HHS to court over a reclassification of its dry eye treatment, claiming the reclassification denies the firm marketing exclusivity and patent listings under the Hatch-Waxman Act.

In a complaint filed in U.S. District Court for the District of Columbia, the firm argues that in March the FDA erroneously reclassified its Restasis (cyclosporine ophthalmic emulsion) 0.05 percent product as an antibiotic, a classification that exempts the product from several benefits and incentives under Hatch-Waxman. The firm claims its patents on Restasis extend until 2014. Restasis was approved by the agency in December 2002 as a nonantibiotic treatment for increasing tear production in patients with dry eyes.

The firm decided to file the suit after CollaGenex Pharmaceuticals obtained a preliminary injunction in July on a similar issue from the same court. The court issued a preliminary injunction preventing the FDA from approving any generic version of CollaGenex's gum disease drug Periostat (doxycycline hyclate) until the court determines whether the product should be classified as an antibiotic.

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FDA FINES LASIK CENTER $1.1 MILLION


An ophthalmologist has been fined $1.1 million by the FDA for violating federal regulations during the clinical trial of a laser system for LASIK surgery.

As part of the Nov. 5 settlement agreement, the Lafayette, La., ophthalmologist, Leon LaHaye, will pay $150,000 and his eye care center will pay $950,000 for 175 clinical study violations, including using an unapproved laser on patients before the trial began and ignoring study parameters. The agreement will go before an administrative law judge for final approval.

[Chris Ryser]

In Today's Bulletin ..............................

FDA WARNS AGAINST INTERNET PRESCRIPTION DRUG PURCHASES



The FDA has warned consumers not to purchase 10 popular pharmaceuticals over the internet or from foreign sources because of the risks involved with their use.

The agency said it could not vouch for the safety of drugs purchased online, since their sources could not be tracked. Furthermore, the agency noted that many websites do not require prescriptions, and users of these drugs could incur serious health risks.

The FDA singled out these 10 drugs:


Accutane (isotretinoin), an acne treatment;

Actiq (fentanyl citrate), for management of severe cancer pain;

Clozaril (clozapine), a schizophrenia drug;

Lotronex (alosetron HCl), for irritable bowel syndrome in women;

Mifeprex (mifepristone or RU-486), for the termination of early intrauterine pregnancy;

Thalomid (thalidomide), for treatment of erythema nodosum leprosum;

Tikosyn (dofetilide), a sinus drug;

Tracleer (bosentan), for pulmonary arterial hypertension;

Trovan (trovafloxacin mesylate), for severe, life-threatening infections; and

Xyrem (sodium oxybate), for the treatment of cataplexy in narcolepsy patients.

[Chris Ryser]

iNTODAY'S BULLETIN .....................................

VISIONCARE COMPLETES ENROLLMENT OF MACULAR DEGENERATION TRIAL


VisionCare Ophthalmic Technologies has completed patient enrollment in its Phase II/III clinical trial for untreatable late-stage age-related macular degeneration.

The trial is evaluating the safety and efficacy of the company's wide-angle implantable miniature telescope in individuals with moderate to severe bilateral central vision impairment associated with late stage dry or scar stage wet age-related macular degeneration. The device is implanted in one eye and allows enlarged central vision images over a wide area of the retina to improve central vision, while the nonoperated eye provides peripheral vision for navigation.

The trial is being conducted at 28 ophthalmic centers across the U.S. and has enrolled more than 200 patients. Patients will be followed up for one year for efficacy and an additional year for safety.

[Chris Ryser]

In Today's Bulletin ..................................

Vol. 4, No. 194
Monday, Oct. 6, 2003

CONTACT LENS BILL REPORTED FAVORABLY

The Fairness to Contact Lens Consumers Act, H.R. 3140, was favorably reported by voice vote at the mark-up session on Oct. 1.

The bill would prohibit manufacturers and any other people engaged in the assembly, sale and distribution of contact lenses from suggesting in ads or sales presentations that the lenses can be obtained without a prescription. The bill would also require sellers to verify the accuracy of contact lens prescriptions, and optometrists and ophthalmologists to provide patients with a copy of the prescription. There was some tightening of technical language at the mark up for clarity.

[Chris Ryser]

In Todays Bulletin ..................................

REFRACTEC FILES PMA FOR PRESBYOPIA PROCEDURE


Refractec has filed for premarket approval with the FDA for its CK Blended Vision for patients with presbyopia or difficulty with near vision.

CK Blended Vision is the first procedure to be reviewed by the FDA specifically for presbyopic patients who want to regain their near vision. The FDA approved CK Blended Vision in 2002 for people over age 40 with hyperopia or farsightedness. The procedure uses radio waves to restore near vision without impacting distance vision.

In a clinical study of the procedure, 97 percent of patients could see 20/20 at a distance and read magazine- and newspaper-size print, and 75 percent of patients could see 20/20 and read phone book-size print.

[Chris Ryser]

Today's Bulletin ..................................

IOWA, MINNESOTA TO CONSIDER REIMPORTATION PROGRAMS


The governors of Iowa and Minnesota have directed their health officials to investigate the possibility of importing prescription drugs from Canada, part of a growing trend among cash-strapped states that could threaten drugmakers' bottom line.

Republican Minnesota Gov. Tim Pawlenty and Democratic Iowa Gov. Tom Vilsack Wednesday announced their states will look into reimportation to help ease costs. Iowa hopes to import drugs for state employees, while Minnesota is considering providing the cheaper drugs for both state employees and those on public assistance.

Iowa and Minnesota join Illinois, California and the city of Springfield, Mass., in investigating the reimportation option. The FDA repeatedly has stated that imported drugs could pose a health risk due to the lack of agency inspections and warned California that the state and its officials could be held liable for complications stemming from unsafe imported drugs.




MDUFMA MEETING TO BE HELD DEC. 3

The FDA will hold a public meeting to discuss the agency's progress in implementing various Medical Device User Fee and Modernization Act of 2002 (MDUFMA) provisions, including the guidances the FDA has issued on the law.

The meeting will be held Wednesday, Dec. 3 at the Hilton Washington D.C. North/Gaithersburg, Md. The meeting is free and preregistration is required by Nov. 3. Preregistration also is required by Nov. 3 to listen to the meeting proceedings from another location. Panels will discuss how the user fee process is working; electronic labeling and identification of the manufacturer on the device; bundling, modular premarket approval applications (PMAs) and expedited PMAs; the third-party inspection program; and reuse.

Individuals may make 10-minute presentations and must submit a topic to be addressed and an abstract by Nov. 3. For more information, contact Sherrie Appel at (301) 443-2845 or saa@cdrh.fda.gov.

[Chris Ryser]

In today's bulletin.....................

HEADS OF PHONY DME COMPANIES CHARGED WITH MEDICARE FRAUD

The U.S. Attorney for the Southern District of Florida has charged eight former executives at bogus durable medical equipment (DME) companies with healthcare fraud.

According to documents filed Sept. 8, Eduardo Mesa, Pablo Garcia, Christine Morales, Humberto Alvarez, Ana Incer, Sergio Carmona, Eduardo Morales and Juan Monduy were each charged with healthcare fraud. The charge carries a maximum prison sentence of 10 years and a fine equal to twice the amount of money defrauded from Medicare.

The U.S. attorney's office alleges the eight executives and others formed bogus DME companies and billed the Medicare program knowing that beneficiaries never received DME services or products.

[Chris Ryser]

In today's bulletin.....................

ALLERGAN COOPERATES WITH FTC ANTICOMPETITON PROBE

Allergan is working with investigators from the FTC in an inquiry into allegations of anticompetitive practices over its eye medication Acular, the firm said.

The company learned of the FTC investigation, which hinges on whether Allergan is trying to stifle generic competition, on May 19. Allergan revealed the nonpublic inquiry as part of its second-quarter report filed with the Securities and Exchange Commission yesterday. Allergan also said in the report it had been sued by Apotex over similar anticompetitive issues regarding Acular (ketorolac tromethamine).

Apotex received tentative FDA approval for generic ketorolac tromethamine this summer. Acular was first approved by the FDA in 1992. In June, the drug received a new indication for the reduction of eye pain after corneal refractive surgery.

[Chris Ryser]

In Todays Bulletin ..................................

FDA ACCEPTS STAAR'S PMA FOR IMPLANTABLE CONTACT LENS

The FDA has accepted Staar Surgical's premarket approval application for its implantable contact lens for substantive review and granted it an expedited review status.

The contact lens is approved for sale in 37 countries. Staar plans to market the device in the U.S. to treat nearsightedness