OverTheCounterToday

Pseudoephedrine Prescription Bill On the Way

"The Tan Sheet" has been on top of tracking efforts to restrict sales of pseudoephedrine since states first began to develop legislation to keep the cough/cold ingredient from being diverted to the production of methamphetamine. Now Oregon Senator Ron Wyden wants to take his state's approach (making PSE prescription-only) national. Read our story, below. To  stay current on this and other issues that affect over-the-counter drugs and dietary supplements, subscribe to "The Tan Sheet" or get a free trial here.

Wyden To Propose Prescription-Only Status For Pseudoephedrine

Legislation drafted by Sen. Ron Wyden would require prescriptions for all products containing the methamphetamine precursor pseudoephedrine.

HHS Secretary Sibelius? It might Spark a Fight

 From our colleagues at the In Vivo blog, here's a great piece on the open spot for HHS secretary:

What we've been telling you for some time is now official: Kansas Governor Kathleen Sebelius is the front-runner to replace Tom Daschle as the nominee for Secretary of Health & Human Services under President Obama.

At least, it is as official as these things get: unnamed "advisers" confirmed to the New York Timesthat she is the leading candidate.

In Washington, DC and other world capitals, this is what is known as a trial balloon. Get the name out there and make sure you have a chance to weigh any vigorous objections before you make the nomination official. The Administration has to make sure it knows the landscape, especially after the collapse of the Daschle nomination threw the White House's carefully crafted plan to launch the health care reform debate into disarray.

Here's the hitch: If the goal is to pick someone who can sail through to confirmation without a fight, it may turn out that Sebelius is not the perfect choice. As we noted, Sebelius is likely to stir up passionate opposition from pro-life members of the Senate.

The Times explains the issue well:

One issue that could draw attention is her stance on abortion. A Roman Catholic who says abortion is wrong, Ms. Sebelius vetoed a bill requiring clinics to report information on why a late-term abortion was performed, drawing the condemnation of the archbishop of Kansas City, Kan.

With that in mind, it can't be a good sign for Sebelius that the Pope himself just issued a statement affirming the view that Catholic politicians are morally obliged to work to end abortion. That was a direct slap at House Speaker Nancy Pelosi, herself a Catholic, who met with Pope Benedict on February 18. (Reuters has the story here.)

But it doesn't seem like a stretch to see the statement as a call to action against Sebelius, who as HHS secretary would oversee everything from stem cell research to regulation of RU-486 to the use of public funds for family planning services.

Stay tuned....

 

- Mike McCaughan

Kweder On Dietary Supplement Regulation

Have you seen anyone who works in the dietary supplement industry today? Did they look like this:

OTC Business News Roundup 2/11/09

Here's a quick roundup of business news for today in the OTC drug world:

 

Mead Johnson IPO

Mead Johnson Nutrionals, marketer of Enfamil formula, began trading today on the NYSE, spun-off by parent Bristol-Myers Squibb in an IPO. Find strategic analysis of the IPO and what it means for BMS, from our colleagues at the In Vivo Blog here. MJN raised $720 million via the IPO Tuesday, Reuters reports here. And for a look at another infant frormula business in transition, get some perspective on Wyeth's nutritionals business in the context of Pfizer's planned acquisition of the company with this story (paid content available to Tan Sheet subscribers. But you can get a free trial here.)

Sanofi Strategy

French drug maker Sanofi-Aventis is looking at small-scale acquisitions in areas including consumer health and biotech, as part of a diversification strategy, the Wall Street Journal reports here.

The In Vivo Blog take is available here.

P&G Tightens Consumer Focus

And for those who missed it last week, looks like Procter & Gamble plans to get out of the prescription drug business--but stay in OTCs. Here is the Reuters story. Look for the next issue of the Tan Sheet for more analysis.

FDA Recall Authority Likely In Peanut Fallout, But Is It The Real Problem?

OK, we've seen him before, but this kid is worth bringing out again for his metaphorical properties, capturing the widespread mess that Peanut Corporation of America's recalls are making. (Notice how his mess has now affected his colleague.)

At The Tan Sheet, we've been keeping a close eye on the peanut product recall - not only because it affects some nutritional bar products in the functional food market, but because it is shaping legislation that will have an impact on FDA and regulated industries. Below is a great analytical piece from this week's issue, taking a look at what the peanut recall could mean for food and dietary supplement manufacturers. Subscribers can read more here, and newcomers can get a trial or a subscription here.

For the latest developments. including PCA's closure of a second plant, read the Associated Press story here.

Here's our story on the peanut recall and a Congressional push for mandatory recall authority for FDA, below:

Hi-Tech In The Big House

MSNBC is reporting that Jared Wheat, founder and CEO of Hi-Tech Pharmaceuticals, has been sentenced in federal court to spend 50 months in prison and pay a $50,000 fine. Other executives from the Norcross, Ga.-based supplement firm already fessed up to Hi-Tech’s scheme of manufacturing counterfeit Rx drugs and selling them over the Internet. The Department of Justice earlier dropped charges against Hi-Tech that its herbal weight-loss supplements were spiked with ephedra.

In August 2008, The Tan Sheet wrote that DoJ’s prosecution of Hi-Tech progressed with the help of FDA, suggesting that the agency could begin more actively pursuing criminal charges against bad actors trafficking in counterfeit pharmaceuticals or tainted supplements. While the brains behind Hi-Tech will have plenty of time to ponder this, other firms engaging in funny business should know they could ultimately face more than just a recall and a slap on the wrist.

FDA Review Planned, Chief Announcement Nigh

President Obama has called for a “full review” of FDA, and the White House has said a nominee to head the agency will be named within days.

The still-expanding recall of products containing peanuts, peanut butter and peanut paste sourced from a Georgia plant found to be contaminated with salmonella is one factor prompting the president to seek a full review of the agency, he said during an interview with the Today Show’s Matt Lauer broadcast Feb. 2.

“The FDA has not been able to catch some of these things as quickly as I expect them to,” President Obama said, noting peanut butter is a regular part of his daughter Sasha’s diet. MSNBC sums up that interview, and provides a transcript, here.

Meanwhile, White House spokesman Robert Gibbs said Friday the President hopes to name a nominee for FDA commissioner within “the next few days.” Here’s what Gibbs had to say:

“I think the revelations have no doubt been alarming, that whether it was our own regulatory system or a company that repeatedly found salmonella in its own testing would continue to ship out that product is beyond disturbing for millions of parents.  The President, like I said, in the coming days will have a new commissioner at FDA and hopefully we'll be able to announce also picks at things like the Consumer Product Safety Commission and places like that to put in place a stricter regulatory structure to ensure that the type of thing that happened in this case doesn't happen again.”

Read the In Vivo Blog’s thoughts on the likely commissioner picks here.

The nomination of Tom Daschle to head the Department of Health and Human Services is being delayed by questions about his taxes. The Finance Committee is expected to meet today to review his case and must clear his nomination before it can go to the full Senate. The Washington Post reports here. 

The Peanut Corporation of America’s outbreak and the subsequent recalls are also the subject of planned hearings to be held by the House energy and Commerce committee, “The Tan Sheet” reports here.

And for lessons PCA’s handling of the contamination has to offer to other manufacturers, read here.