This Day On The Street
Continue to site right-arrow
This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here
Stocks Under $10 with 50-100% upside potential - 14 days FREE!

FDA Mulls Easier Access to Cholesterol Drugs

And no drug discussion would be complete without a financial component. Companies have an incentive for seeking OTC status for prescription drugs that are experiencing weakening sales and/or generic competition. This way, companies can use their brand names to capture some sales that would have been lost.

Mevacor's U.S. sales have virtually disappeared due to generic competition. Pravachol, which ranks third in U.S. statin sales, will lose its U.S. patent protection in April 2006.

For the week ended Nov. 12, Pravachol had a U.S. dollar market share of 11.9%, or $39.2 million, according to NDCHealth, a health care information company. The market leader is Pfizer's (PFE) Lipitor, with a 49% market share, followed by Merck's Zocor, with 25.2%. Zocor, which has lost patent protection in some foreign markets, will be hit by generic competition in mid-2006.

For the week ended Nov. 12, Mevacor had U.S. sales of only $233,314 compared with sales of $13.8 million for generic versions, says NDCHealth. The firm tracks drugs that are dispensed in retail outlets and by mail-order pharmacies. The dollar amounts represent the estimated cost incurred by the wholesaler to purchase product from the drug manufacturer.

Pros And Cons

One way to examine the OTC statin debate is to compare dueling editorials by The Lancet, which opposes nonprescription statins and The American Journal of Cardiology, which says they could provide a benefit.

Shortly before Merck and J&J began selling an OTC version of Zocor in the U.K., The Lancet attacked the British government's decision for becoming the first country to allow a nonprescription statin. It argued that the government failed to require adequate tests on patients who self-medicate and to secure proof that people wouldn't simply "substitute drug use for lifestyle modification," such as losing weight and stopping smoking.

"Will pharmacists have the time to determine the individual's risk of coronary heart disease before selling the drug and also give lifestyle advice?" the editorial asked. "All these are unknowns, which is unfortunate for the U.K. public, who will be the guinea pigs in this large-scale OTC experiment."

3 of 4

Select the service that is right for you!

Action Alerts PLUS
Try it NOW

Jim Cramer and Stephanie Link actively manage a real portfolio and reveal their money management tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
  • Weekly roundups
TheStreet Quant Ratings
Try it NOW
Only $49.95/yr

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
  • Upgrade/downgrade alerts
Stocks Under $10
Try it NOW

David Peltier, uncovers low dollar stocks with extraordinary upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
  • Weekly roundups
Dividend Stock Advisor
Try it NOW

Jim Cramer's protege, David Peltier, identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.

Product Features:
  • Diversified model portfolio of dividend stocks
  • Alerts when market news affect the portfolio
  • Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
Real Money Pro
Try it NOW

All of Real Money, plus 15 more of Wall Street's sharpest minds delivering actionable trading ideas, a comprehensive look at the market, and fundamental and technical analysis.

Product Features:
  • Real Money + Doug Kass Plus 15 more Wall Street Pros
  • Intraday commentary & news
  • Ultra-actionable trading ideas
Options Profits
Try it NOW

Our options trading pros provide daily market commentary and over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.

Product Features:
  • 100+ monthly options trading ideas
  • Actionable options commentary & news
  • Real-time trading community
  • Options TV
To begin commenting right away, you can log in below using your Disqus, Facebook, Twitter, OpenID or Yahoo login credentials. Alternatively, you can post a comment as a "guest" just by entering an email address. Your use of the commenting tool is subject to multiple terms of service/use and privacy policies - see here for more details.
Submit an article to us!


DOW 17,617.81 +260.94 1.50%
S&P 500 2,039.93 +27.04 1.34%
NASDAQ 4,707.4120 +63.10 1.36%

Brokerage Partners

Rates from

  • Mortgage
  • Credit Cards
  • Auto

Free Newsletters from TheStreet

My Subscriptions:

After the Bell

Before the Bell

Booyah! Newsletter

Midday Bell

TheStreet Top 10 Stories

Winners & Losers

Register for Newsletters
Top Rated Stocks Top Rated Funds Top Rated ETFs