Generic ADHD Drugs Not Bioequivalent?

In November 2014, the FDA changed the ratings for two generic versions of Concerta, meaning the generics can no longer be substituted for the brand-name drug. This resulted when, after reviewing side-effect reports where some patients were not getting the expected drug effect, the FDA analyzed the generics (Mallinckrodt and UCB) and found they were not bioequivalent. Now, the generic companies are questioning the FDA's action. The question they raise is "To what extent should the FDA be allowed to reclassify a generic drug when the agency believes it is no longer equivalent to the brand-name version?"

The issue is being raised in an unusual lawsuit claiming the agency overstepped its bounds by deciding two generic drugs used to treat ADHD should no longer be substituted for the widely used Concerta treatment. And the outcome of the case may have implications for generic drug makers and the FDA.

The FDA gave the generic companies six months to provide data showing bioequivalency to Concerta or their drugs should be withdrawn from the market. Now, the deadline has passed but the generics remain available, and it is unclear how the FDA will proceed. An agency spokeswoman would not comment.

A UCB spokesperson says it is working with the FDA to meet its requirement. Mallinckrodt, however, is not showing any signs of complying with the agency mandate. Mallinckrodt has challenged the authority of the agency to reclassify its generic by arguing the FDA failed to provide sufficient notice of its decision and violated its Constitutional rights. In addition, Mallinckrodt states that the FDA has acknowledged there are no safety issues and patients should continue taking the generics if they are not experiencing problems. Mallinckrodt chief executive Mark Trudeau says they plan to sell its generic for the "foreseeable future."

The generics are still available, and the Mallinckrodt generic can be prescribed in "virtually every state in the nation," depending upon state regulations. From a practical standpoint, new ADHD patients may be prescribed a drug that is not therapeutically equivalent to brand-name Concerta.

The FDA has reclassified generic drugs over equivalency before this case; in 2012, the agency changed ratings for some generic antidepressants. However, this challenge by Mallinckrodt is a first.

These events pose an interesting situation because we now have two "categories" of generic Concerta available that are not bioequivalent; "Clinical Pharmaceutics" is the basis for this unique regulatory situation.

Next week, we will look at another example of "Clinical Pharmaceutics."

Looking Ahead!

The new issue of IJPC has two articles by Michael Akers, PhD:

• "Quality Assurance and Quality Control, Part 2" completes the discussion on finished preparation release checks and tests, and concludes with additional information on quality risk assessments/risk management and also on Quality By Design.
• "Contamination Control" discusses the risks, sources, facilities, water, air, sanitization/disinfection agents, environmental control evaluation, viable particles, and pyrogens/endotoxins, and provides a take on the Practical Realities of Environmental Monitoring.

Dr. Akers is the author of Sterile Drug Products: Formulation, Packaging, Manufacturing, and Quality and has written many articles for IJPC this year for the benefit of compounding pharmacists.

News

CVS Expands Buying Omnicare
CVS Health Corp. is purchasing the nursing-home pharmacy Omnicare Inc. in a deal valued at $12.7 billion; this enhances their services for the elderly and increases its position as the biggest U.S. retailer of prescription drugs. The acquisition puts CVS in position to provide drugs to a growing market as the U.S. population ages; Omnicare delivers drugs and helps senior-living facilities manage residents' medications. As the demand for pharmacy services rises and drug prices increase, insurers and companies look for ways to manage costs; pharmacy-service providers are combining to gain a bigger piece of the growing market.
http://www.bloomberg.com/news/articles/2015-05-21/cvs-to-buy-omnicare-in-12-7-billion-deal-for-pharmacy-expansion-i9y39jub

Texas Pharmacy Victory v. PBMs
In a major victory for Texas Pharmacy (TPA), Senate Bill 94, relating to certain fees charged for adjudication of claims under health-benefit plans, was signed into law on Friday, May 15. The bill bans pharmacy benefit managers (PBM)-assessed transaction fees, and it is estimated that it will save Texas pharmacies millions of dollars each year. The bill overcame PBM opposition and strengthens the current prohibition of pharmacy transaction fees by:

• adding pharmacies to the list of health-care providers that cannot be assessed a transaction fee;
• prohibiting fees for network management services, inclusion in a network, services related to the adjudication of a claim, services for processing a claim, services related to transmitting a claim, or for developing a claims processing and adjudication network;
  
  and
  
  
• giving the Texas Dept. of Insurance stronger enforcement capabilities

TPA was proud to work closely with the Texas Pharmacy Business Council and the other pharmacy organizations to pass this crucial piece of legislation. This is an extremely important piece of legislation for pharmacies that continue to be charged excessive transactional fees from PBMs, despite legal prohibitions against them. Now that the legislation has been signed by the Governor, the law will go into effect on September 1, 2015.
http://www.texaspharmacy.org/

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Did You Know ...

�that Memorial Day, a federal holiday in the U.S., is set aside for remembering those who died while serving in the country's armed forces? It is observed annually on the last Monday of May. It was formerly designated Decoration Day and originated after the American Civil War to commemorate the Union and Confederate soldiers who died in the war. By the 20th century, Memorial Day had been extended to honor all Americans who died while in the military service. It is generally noted to be the beginning of the summer vacation season, which lasts until Labor Day.

Tip of the Week

Remember, "Memorial Day" is not about sales at department stores, etc., it is a time of remembrance of all those who have served and is celebrated in church services, local rallies, picnics, family gatherings, etc.

Looking Back

Said Farmer Brown,
Who's bald on top,
"Wish I could
Rotate the crop!"
     Burma Shave