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JAMA study criticizes FDA regulation of supplements for failure to remove banned substances from market

BY Michael Johnsen

CHICAGO — A JAMA study noted that about two-thirds of dietary supplements recalled by the Food and Drug Administration still contained banned ingredients at least six months after being recalled, according to a study in the journal's October 22/29 issue.
 
"Action by the FDA has not been completely effective in eliminating all potentially dangerous adulterated supplements from the U.S. marketplace," said Pieter Cohen of Harvard Medical School, who conducted the study. "More aggressive enforcement of the law, changes to the law to increase the FDA's enforcement powers, or both will be required if sales of these products are to be prevented in the future."
 
“Any time adulterated health products get to consumers or remain on the market after the FDA has determined they are potentially unsafe illustrates a weakness in the enforcement of the nation’s food and drug laws," stated Steve Mister, president and CEO for the Council for Responsible Nutrition. "Responsible manufacturers and marketers of dietary supplements applaud strong enforcement measures by FDA to address illegal products that contain undisclosed, active pharmaceutical ingredients. We have zero tolerance for this problem and welcome not only recalls, but also criminal enforcement against companies that put consumers at risk."
 
The Natural Products Association also announced its support of FDA’s efforts to crack down on any manufacturer selling adulterated dietary supplements. "Studies like this should remind consumers that it is very important to be wary of promises that sound too good to be true and products which primarily are offered online," observed NPA CEO and executive director Daniel Fabricant. "Unfortunately, there are scam artists whose only motivation is money, not consumer safety, and these are the ones continuing to put consumers at risk.”
 
According to the study, the FDA recalled 274 dietary supplements between January 2009 and December 2012. Twenty-seven of the 274 recalled supplements (9.9%) met inclusion criteria for the study and were analyzed using the same methods at the FDA's laboratories (e.g., gas chromatography/mass spectrometry). Supplements were purchased an average of 34.3 months (range 8-52 months) after the FDA recall. As many as 74% of supplements were produced by U.S. manufacturers.
 
The researchers found that one or more pharmaceutical adulterant was identified in 66.7% (18 out of 27) of recalled supplements still available for purchase. Supplements remained adulterated in 85% (11/13) of those for sports enhancement, 67% (6/9) for weight loss and 20% (1/5) for sexual enhancement. Of the subset of supplements produced by U.S. manufacturers, 65% (13/20) remained adulterated with banned ingredients.
 
Turning the research on its head, CRN noted that nine in 10 banned supplements are no longer available for purchase, suggesting that the FDA action is largely successful. "Of the 27 remaining, 18 of the products were identified as containing APIs after being recalled; the other nine had been reformulated. In other words, the FDA’s recall efforts had a more than 93% success rate (256 out of 274)."
 
"We note also, that once these products were identified by FDA as containing undisclosed APIs, they were recalled under FDA’s ample authority for regulating adulterated drugs — because they are just that, adulterated drugs, regardless of how they were marketed," Mister said. "Increased resources to enforce the nation’s drug laws would more directly address the problem and help reduce the number of unrepentant products to zero. Yet the researchers jump to the recommendation that changes in the law to increase FDA’s powers over dietary supplements are needed, illustrating their call to action is a ‘solution in search of a problem.’" 
 
Banned substances identified in recalled supplements included sibutramine, sibutramine analogs, sildenafil, fluoxetine, phenolphthalein, aromatase inhibitor, and various anabolic steroids.
 
The FDA initiates class I drug recalls when products have the reasonable possibility of causing serious adverse health consequences or death. Recently, the FDA has used class I drug recalls in an effort to remove dietary supplements adulterated with pharmaceutical ingredients from U.S. markets. According to Cohen, prior research has found that even after FDA recalls, dietary supplements remain available on store shelves. 
 
 
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Family Dollar complies to FTC second requests for both Dollar Tree and Dollar General proposals

BY Michael Johnsen

MATTHEWS, N.C. — Family Dollar Stores on Tuesday announced that it has certified substantial compliance with both the Federal Trade Commission’s second request regarding the acquisition by Dollar Tree, as well as the second request regarding Dollar General's bid for the company. 

Dollar Tree is expected to certify substantial compliance by Nov. 7, the company stated, however Family Dollar has no insight as to when Dollar General will comply with the FTC's second request. Family Dollar continues to believe, based on its discussions with the FTC staff, that the FTC review of the Dollar General tender offer will continue well into 2015, the company stated.
 
Once all parties have certified that they have substantially complied with FTC's second request, the Commission has 30 additional days to complete its review of the transaction and to take action if necessary.
 
Family Dollar is committed to cooperating with the FTC’s investigations of both transactions, and providing all of the necessary information from Family Dollar for the FTC to advance its review of both potential transactions as promptly as practicable.

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NCPA: Energy ‘positive’ during 116th Annual Convention

BY Antoinette Alexander

AUSTIN, Texas — Hundreds of attendees gathered in Austin, Texas, to attend the National Community Pharmacists Association’s 116th Annual Convention and Trade Exposition — a meeting marked with positive energy and optimism for the future of community pharmacy.

“This is the first time in NCPA’s 116-year history that we’ve been in Austin and it has been a great meeting for us,” NCPA CEO B. Douglas Hoey said during a media briefing on Tuesday. “… The personality of this meeting is one of positive energy and really looking toward the future. It has been an exciting time in Austin."

Roughly 300 attendees flocked to the Austin Convention Center to attend the event, held Oct. 18 to 22.

During Hoey’s Convention address, he highlighted several key issues that, according to an NCPA survey in late 2013, are top of mind for NCPA members. NCPA represents the interests of America's community pharmacists, including the owners of more than 23,000 independent community pharmacies.

The critical issues Hoey addressed include:

  • The exclusion of independent and regional pharmacies from Part D preferred networks. Responding to the concern and ramping up efforts to resolve the issue, the NCPA “has seen what appears to be some demonstrable progress in allowing independent community pharmacies and regional chains to be able to participate in Part D preferred networks in 2015,” Hoey said. However, more work lies ahead and Hoey stressed that it is “not a case of declaring victory, but it is certainly a case of declaring major progress.”
  • Reimbursements on generic medications are trailing increasing generic pricing. “Over the last year and a half, hundreds of generic prices have been exploding in price. For example, a common steroid cream going from $100 for a tube to $250 for a tube, and that’s a real example. … It is really standing on its head the conventional wisdom that generic products are always less expensive than brands. While that is still usually true, it is no longer an automatic,” Hoey said. “So, because of that change in the marketplace it has really exacerbated a practice in our industry and that is when the price goes up on the product the payment rate to the pharmacy does not go up.” Hoey said NCPA has asked Congress to look into why generic drug prices are soaring and there’s a lag in the changes to pharmacy rates.
  • Pay-for-performance networks of pharmacy. “With CMS’ quality measures tied to star ratings, there is a high interest both by pharmacies and by payors in increasing the plan star ratings through these quality measures,” Hoey explained. “We are encouraging pharmacies to increase those quality measures to get them as high as possible, but we also think that pharmacies are going to begin developing networks based on these quality measures.” Hoey went on to highlight NCPA’s “Simplify My Meds” medication synchronization program to boost adherence. More than 2,000 independent pharmacies have signed up for the program and have enrolled more than 75,000 patients who are now experiencing better adherence and outcomes. Meanwhile, many other pharmacies are participating in similar programs to improve patient medication adherence.

In providing an update on the legislative and regulatory front, Steve Pfister, NCPA SVP, government affairs, said NCPA continues to reach out to Congress in support of H.R. 4577, The Ensuring Seniors Access to Local Pharmacies Act, which was introduced in May.

Another priority among NCPA members is H.R. 4437, the Generic Drug Pricing Transparency Act, Pfister said. “Perhaps most significantly, as far as developments on the generic pricing issue, is what has occurred over the last couple of weeks."

On Oct. 2, Rep. Elijah E. Cummings, ranking member of the House Committee on Oversight and Government Reform, and Sen. Bernard Sanders, chairman of the Subcommittee on Primary Health and Aging, Senate Committee on Health, Education, Labor and Pensions, sent letters to 14 drug manufacturers requesting information about the higher prices they have been charging for generic drugs. This has since been followed up with a letter to HHS, calling on the Obama Administration to look into the price spikes, Pfister said.

“We will continue to monitor this closely and we are very hopeful that during the lame duck session of Congress that there will be an oversight hearing conducted on this issue, which has been very problematic for community pharmacy,” Pfister said.

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