Pubdate: Sun, 16 Jul 2006
Source: Star-Ledger (Newark, NJ)
Copyright: 2006 Newark Morning Ledger Co
Author: Robert Cohen, Star-Ledger Washington Bureau
Bookmark: (Methamphetamine)


Letter Cites Neil Labs For Dozens Of Violations

WASHINGTON -- Neil Laboratories, a manufacturer of prescription and 
over-the-counter medicines, describes itself on its Web site as "an 
upcoming young dynamic" company committed to the safety and efficacy 
of its products.

But the public record offers a different picture of the privately 
held East Windsor pharmaceutical company.

Last month, the Food and Drug Administration charged Neil Labs with 
selling adulterated and unapproved prescription drugs, as well as 
mislabeling over-the-counter medications.

This was the third formal FDA warning letter sent to the company 
since 1997 for manufacturing, drug quality and other violations. Neil 
was also among a group of companies cited in a separate 2002 FDA 
letter for selling a cold remedy without government approval.

Bharat Patel, the chief executive of Neil Laboratories, said his 
company has responded to the issues cited by the FDA.

"We don't want to say anything right now. We are promising the agency 
to remain in compliance and to work with the agency," said Patel. 
"These are observations made by the FDA when they inspected our 
plant, and we correct them and go forward."

Government documents show the Drug Enforcement Administration issued 
29 warning letters to the company between 1999 and 2001 for selling 
pseudoephedrine tablets that were later diverted to the 
methamphetamine black market.

DEA agents raided the company's headquarters in 2002 as part of a 
nationwide investigation, seizing "multiple tons of ephedrine and 
pseudoephedrine" and arresting a part-owner of the company who later 
served jail time. Pseudoephedrine, a nasal decongestant, and 
ephedrine, a stimulant and cold remedy, can be used in the illicit 
manufacture of methamphetamine, or "speed."

The latest FDA letter warned Neil Laboratories that failure to 
correct the violations could result in "seizure of your products," or 
a civil injunction that would bar continued production or 
distribution of the company's products.

An FDA spokeswoman said the letter shows the agency considers the 
violations "significant," but she declined further comment.

Neil Laboratories is one of hundreds of companies that make low-cost 
generic drugs, which are copies of brand-name prescription medicines, 
and produce over-the-counter medicines that are available to 
consumers without a prescription.

Its products have included pain relievers, allergy medicines, 
laxatives and cough and cold remedies.

According to a June report by D&B, the business information service, 
Neil Labs has estimated annual sales of $4.1 million and employs 
about 34 people.

The generic drug industry, plagued by scandal in the late 1980s and 
early 1990s, has matured and grown rapidly, with annual sales 
estimated to be $28 billion. But serious problems continue to occur.

Last year, Able Laboratories, another New Jersey generic drug company 
with a troubled history of FDA violations, was forced to halt 
manufacturing and recall all of its medicines after serious questions 
were raised about quality control data used to obtain approval for 
its products. The company, which had been publicly traded, has since 
declared bankruptcy.

Neil's most recent problems were revealed in a May 31 warning letter 
publicly released in June that listed a litany of violations 
involving more than two dozen prescription and over-the-counter medications.

Based on an inspection of its East Windsor manufacturing facility in 
December, the FDA listed 13 products for which it said the company 
failed to establish scientifically sound testing procedures to ensure 
the drugs met proper standards for identity, strength, quality and purity.

It also found the company failed to maintain laboratory records with 
complete data from all tests, and failed to assure that individuals 
responsible for supervising the manufacture and processing of drug 
products had the proper education, training and experience.

In addition, the warning letter accused Neil of marketing eight 
prescription drugs not approved for sale by the FDA. The drugs, 
including a combination of pseudoephedrine HCI and guaifenesin in 120 
mg/600 mg tablets, were sold in "time released dosage forms" that the 
FDA said are "not generally recognized as safe and effective." 
Guaifenesin is an expectorant used to clear mucus from the chest.

The FDA said Neil mislabeled four over-the-counter products, 
including aspirin bottles that lacked complete Reyes syndrome 
warnings or specific pregnancy warnings, as required by law.

The letter was the latest in a series of FDA warnings:

In October 2002, the FDA cited Neil along with other firms for 
marketing three separate single-ingredient extended-release 
guaifenesin products without FDA approval.

In October 2001, the FDA charged the company with a series of 
manufacturing violations that it said made it impossible to ensure 
the safety and effectiveness of some of its products.

In 1997, the company was charged with failing to ensure the purity 
and quality of its products, improper maintenance and controls in its 
laboratories, and poor quality of some of its medications.

Separately, the company was a target of nationwide DEA probe into the 
illicit drug trade. In 2002, DEA agents armed with a search warrant 
descended on the company's headquarters and arrested Mantu Patel, the 
firm's production manager, a shareholder and brother of CEO Bharat Patel.

Mantu Patel was charged with supplying the chemical pseudoephedrine 
to the methamphetamine trade, but the charge was dropped in 2004 and 
Patel pleaded guilty to record-keeping violations. He was sentenced 
to one year in jail.

After the 2002 raid, the DEA temporarily suspended the company's 
registration to manufacture and distribute products containing 
ephedrine and pseudoephredrine. A federal judge subsequently upheld 
the DEA's claim that the firm's activities constituted an "imminent 
danger to public health and safety."

Patel, Neil's CEO, said the issues have been resolved with the DEA. 
He said his company was "not involved in any capacity with a 
diversion," maintaining the abuse involved the customers who 
purchased the products from his company.

"We had no control," he said.

In 2003, Neil Labs formally agreed to surrender its registration to 
manufacture a group of chemicals including ephedrine and 
pseudoephedrine, and it agreed not to make or distribute over-the 
counter pharmaceuticals containing those ingredients. But DEA 
spokesman Douglas Collier said the company can still purchase these 
ingredients from registered manufacturers for use in some of their products.

Collier said the company remains on the agency's "watch list."

What Consumers Can Do

The Food and Drug Administration found numerous prescription drugs 
and over-the-counter medications made by Neil Laboratories were 
manufactured improperly, marketed without formal approval or 
contained inadequate patient warnings. Consumers can check package 
labeling and inserts or consult a pharmacist to determine if their 
medicines were made by the company. Below is a list of Neil 
Laboratories drugs flagged by the FDA.

# Drugs that didn't conform with good manufacturing standards to 
assure appropriate identity, strength, quality, and purity:

Guaifenesin 400 mg Caplets

Guaifenesin/Pseudoephedrine Caplets 600 mg/120 mg and 1200 mg/50 mg

Guaifenesin/Pseudoephedrine Sustained Release Caplets 800 mg/90 mg

Guaifenesin/Dextromethorphan Caplets 400 mg/20 mg and 1000 mg/60 mg

Guaifenesin/Pseudoephedrine/Dextromethorphan Caplets 800 mg/90 mg/60 mg

Guaifenesin/Phenylephrine Caplets 1200 mg/40 mg

Bromphenirimine/Pseudoephedrine Caplets 10 mg/120 mg

Isoxsuprine 20 mg Tablets

Sennoside 8.6 mg Tablets

Sennoside/Docusate sodium 8.6 mg/50 mg Tablets

Bisacodyl 15 mg Tablets

Calcium Polycarbophil 625 mg Caplets

Aspirin 800 mg Sustained Release Caplets.

# Unapproved drugs made in timed-release dosage forms not generally 
recognized as safe and effective by the FDA:

Aspirin 800 mg Sustained-Release Tablets

Pseudoephedrine HCI and Guaifenesin 120 mg/600 mg Sustained-Release Tablets

Guaifenesin 1000 mg and Dextromethorphan HBr 60 mg Long-Acting Tablets

Pseudoephedrine HCI 90 mg and Guaifenesin 800 mg Time-Released Tablets

Dextromethorphan HBr 60 mg, Pseudoephedrine 90 mg, and Guaifenesin 
800 mg Time-Released Tablets

Guaifenesin 1200 mg and Phenylepherine HCI 40 mg Sustained-Release tablets

Pseudoephedrine HCI 50 mg and Guaifenesin 1200 mg Sustained-Release tablets

Uni-Tex 120/10 (Pseudoephedrine HCI 120 mg/Brompheniramine maleate 10 
mg) Extended-Release Capsules.

# Over-the-counter drugs the FDA found were misbranded:

Health Care America Aspirin 325 mg film-coated tablets; Health Care 
America Enteric Coated Aspirin 325 mg tablets; Health Care America 81 
mg Low Dose Aspirin tablets; NC Low Dose EC Aspirin 81 mg tablets. 
(These drugs failed to bear the complete Reye's syndrome warning and 
failed have a complete warning regarding the use of aspirin in the 
third trimester of pregnancy.)

Preferred Plus Pharmacy Enteric Coated Aspirin 500 mg tablets. 
(Failed to bear the complete Reye's syndrome warning and failed to 
have the alcohol warning for aspirin products.)

Health Care America Total Allergy Medicine (25 mg diphenhydramine 
hydrochloride), two-piece banded capsules packaged in bottles; NL 
Diphenhydramine Hydrochloride (25 mg and 50 mg), two-piece banded 
capsules packaged in bottles. (Failed to carry proper labeling statements.)

URL Guaifenesin 400 mg tablets; NL Guaifenesin 400 mg tablets. 
(Labeling statements did not meet FDA standards.)

Source: Food and Drug Administration
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MAP posted-by: Beth Wehrman