OverTheCounterToday

House Slows Momentum On Food Safety

House proponents of food safety reform suffered a setback today in their attempt to pass a bill before the August recess, but they say they are optimistic about enacting the legislation.

The Food Safety Enhancement Act, H.R. 2749, failed to draw a two-thirds majority during a vote under suspension of the rules. The House voted 280-150 for the bill, but a  majority of 290 is needed to pass bills considered under suspension, which limits debate time and cuts off amendments.

The bill's failure to pass smoothly likely surprised supporters, particularly the Energy and Commerce Committee, which introduced the act and unanimously supported it in June. Some House members have said the bill should not be pushed through quickly and others have concerns about the legislation's impact on agricultural interests. 

H.R. 2749's initial author and a key proponent of food safety reform, Rep. John Dingell, D-Mich., said he anticipates adding the bill to the July 30 floor schedule. However, if the legislation is not voted on before Congress recesses for the month on Aug. 3, it likely will not be taken up until September.

"With 280 votes, the bill clearly has broad bipartisan support and I am a little disheartened that Americans will have to wait a little longer now to feel safe about their food supply again," Dingell said in a release.

Canadian Firm Hopes To Turn Failed IND Into Supplement NDI

 

After failing to achieve significant results in drug trials with Alzheimer's disease patients, homotaurine amino acid is getting a second crack at entering the market -- this time as a dietary supplement component. Quebec-based Ovos Natural Health submitted a citizen petition June 26 requesting FDA allow marketing of homotaurine as a new dietary ingredient. 

The petition is the first to seek this path to market for a failed investigational new drug. 

Attorney Marc Ullman, who submitted the petition on behalf of Ovos, said if FDA promulgates a regulation allowing homotaurine as an NDI, it will set the regulatory bar at a "reasonable height" and prove to companies "there is a way that they can successfully negotiate the process."

Singulair First-In-Class Switch On Merck's OTC Horizon?

Merck may seek a OTC switch of its best-selling Singulair prescription medication, asking for a nonprescription indication for allergic rhinitis.

In addition to acknowledging it is considering applying to switch Singulair, which also is indicated for allergic rhinitis, Merck says it looks to expand its consumer health business as the closing of its Schering-Plough acquisition approaches.

During Merck's July 21 earnings call, executive VP Ken Frazier said the firm is not ready to declare a strategy for a Singulair switch, but he disclosed that Merck is examining the issue seriously in part because of the product's August 2012 patent expiry.

“We’re not in a position today to declare where we see Singulair OTC being, but it’s something we are looking at very carefully. It is a brand that’s had broad acceptance for allergic rhinitis and asthma. We believe it is a safe, effective product,” said Frazier, who is also president of Merck’s Global Human Health division.

“So that’s something that we will evaluate along with the FDA and others to decide … the best way to bring that forward in the context of OTC.”

While Singulair has FDA approval for treating asthmas as well as allergic rhinitis, Merck likely would seek a switch as an allergy product given the difficulty of gaining the agency's approval for a nonprescription asthma product.

Singulair generated $4.3 billion in sales in 2008 and accounted for 22 percent of Merck's overall revenue in the firm's fiscal 2009 second quarter. The firm said ther product's sales increased 16 percent to $1.3 billion during the quarter.

Legislation Proposes Including Supplements In Health Care Reform

The supplement industry continues pushing for a role in health care reform, as Rep. Dan Burton, R-Ind., introduces legislation July 20 to make dietary supplements, foods for special dietary use and medical foods eligible as deductible medical expenses.

The language in the Dietary Supplement Tax Fairness Act of 2009, H.R. 3263, has appeared in previous legislation, but not with health care reform a top priority in Congress.

Burton's bill would amend the Internal Revenue Code of 1986 to treat as medical expenses foods and supplements that "comply with applicable good manufacturing practices prescribed by the Food and Drug Administration or with other comparable standards."

"The Tan Sheet" noted a previous incarnation of the bill, the Dietary Supplement and Health Meal Replacement Tax Parity Act of 2007, here. That version was introduced by Rep. Edolphus Towns, D-N.Y., now chairman of the House Oversight and Government Reform Committee.

Government affairs executives in the supplement industry say Burton's bill is likely too broad to move in Congress. They are looking ahead instead to separate legislation that aims to allow purchases of dietary supplements and meal replacement products under flexible spending arrangements, and only if the products are eligible for a full or qualified health claim.

Reckitt: Mucinex ANDAs Should Cough Up Bioequivalence

Add a citizen petition to Reckitt Benckiser's list of strategies for trying to prevent or delay the introduction of private-label competition to the Mucinex line of expectorant/cough suppressant OTCs.

Reckitt is asking FDA to subject abbreviated new drug applications for generics of modified-release formulations of Mucinex products to the "same bioequivalence requirements" for approval as the original products.

The U.K. firm, which has reported substantial revenue growth since gaining Mucinex and other brands in its 2007 acquisition of Adams Respiratory Therapeutics, submitted its petition to FDA July 14.

OTC Coverage Loses Out In House Ways And Means Health Care Reform Bill

Many consumers' insurance options for over-the-counter health care products likely would be cut under the House Ways and Means Committee's health care reform legislation.

Ways and Means Chairman Charlie Rangel's amendment to the America's Affordable Health Choices Act, H.R. 3200, disqualifies OTC drug purchases as medical expenses that are reimbursable with excludible income under flexible spending arrangements or eligible for distributions from health savings accounts. (A summary of the amendment is available here.)

"Reimbursement for expenses incurred for a medicine or a drug shall be treated as a reimbursement for medical expenses only if such medicine or drug is a prescribed drug or is insulin," the New York Democrat's amendment reads.

The amended legislation passed out of committee early July 17 by a 23-18 vote largely along party lines. Three Democrats defected to oppose the bill.

Harkin Takes Aim At Efforts To Undo DSHEA

  

Sen. Tom Harkin wants the supplement industry to know that any changes to the Dietary Supplement Health and Education Act will have to go through him. The Iowa Democrat and long-time industry ally told attendees at the Natural MarketPlace conference and trade show July 11 in Las Vegas that the 1994 law "is not going anywhere."

"I've got good staff on top of this. We have our friends in the House who have staff on this," he said. "We're going to be keeping our eyes open for anything that might come through that would in any way undo or restrict DSHEA."

Harkin expressed concern, however, that House Energy and Commerce Committee Chairman Henry Waxman, D-Calif., might take a back-door approach to weakening DSHEA via a "simple little amendment on some bill that has to go through."

Teva Stays One Step Ahead Of Generics With Single-Dose Plan B

Teva Pharmaceutical Industries will likely extend its market exclusivity to Plan B emergency contraceptive via a new dosage formulation. A spokeswoman said the company expects to have three years of exclusivity for its levonorgestrel 1.5-mg tablet Plan B One-Step, or until July 10, 2012.

   

The firm announced the drug's approval by FDA today. 

Teva's exclusivity for Plan B in its two-dose 0.75-mg formulation expires Aug. 24. The firm is discontinuing the two-dose formulation and expects to have One-Step available by August, the spokeswoman said.

In addition to approving the single-dose contraceptive, FDA has also granted Plan B nonprescription access to women 17 years old, which it said it would do following a court decision that objected to the agency's original Plan B approval process (as Over the Counter Today discussed here and "The Tan Sheet" reported here).

FDA On Notice To Solve Sec. 912 Puzzle

 

Senate members say FDA must decide whether the agency will implement a provision of the FDA Amendments Act of 2007 in a way that could substantially stifle innovation in the dietary supplement industry.

 

Sec. 912 of FDAAA would amend the Food, Drug and Cosmetic Act to prohibit interstate sale of foods that have an added approved drug, licensed biological or a product -- such as an ingredient -- that underwent publicly disclosed substantial clinical investigation.

 

In the Senate Appropriations Committee's report for FDA's fiscal 2010 spending, the members recommend the agency decide how Sec. 912 will apply to dietary supplements.

 

Under a "definition of food" heading, the report says FDA closed the comment window on the question in October 2008, but "more than eight months later, FDA still has not resolved the issue."

 

"The committee directs FDA to dispose of this issue," according to the report, though it does set a deadline.

 

Supplement industry stakeholders are concerned that, if interpreted broadly, Sec. 912 would stifle innovation by preventing firms from researching ingredients because doing so might bar their introduction altogether. "The Tan Sheet" reported industry's misgivings about the provision here and here.

Marketer Says FDA Warns Consumers About Products Recalled In February

 

Undisclosed prescription ingredients found in weight-loss or sexual enhancement pills are not behind the latest dietary supplement recall – instead, it's knife blades found in energy and whey protein drinks manufactured by Protica, Inc.

However, the firm marketing the New Whey brand protein drinks, IDS of Oviedo, Fla., says it recalled two lots of the product in February after a blade was discovered during a routine quality assurance inspection at its warehouse. FDA did not contact the firm and the agency's July 5 recall announcement "came out of left field," a company spokesman said.

Golden, Colo.-based iSatori Technologies distributes the recalled energy drinks also manufactured by Protica, Hardcore Energize Bullet. ISatori could not be reached to comment.

FDA said a utility knife blade was found in one 2.9-ounce container each of New Whey, which is marketed in the U.S. and Canada, and Hardcore Energize Bullet, which is available in Canada. No injuries linked to the products have been reported.