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Will Cheaper Drugs Be Safe For Seniors?

By: Thair Phillips, RetireSafe President

One of the great success stories in America is the relentless advance of medical science.  Entrepreneurship and innovation has allowed new medical treatments and medications to improve the lives of people around the world. Pharmaceutical breakthroughs have been especially important to senior citizens, allowing many to enjoy longer, more active and productive lives.

Generic drug manufacturers can play a role in holding down medical costs and stretching the fixed income budgets of millions of seniors who often require multiple medications.  But sometimes, in that rush to save money, generic pharmaceutical companies and federal drug regulators try to gallop ahead of the ability of our safety and regulatory apparatus to make sure new medicines are safe.

The most current example involves a certain segment of pharmaceuticals called biologics.  Unlike more traditional medicines, biologics involve the use of organic proteins and carbohydrates.  Biologics have paved the way for more effective treatments of diabetes, blood clots, deep vein thrombosis, multiple sclerosis and other medical conditions prevalent among older patients.  Advances in medical science are keeping the Baby Boom generation alive longer, and this will only multiply the need for biologics among senior citizens.

Traditional small-molecule drugs, like the pills used to treat high cholesterol or high blood pressure, are made of chemical compounds that can be combined in the manner of a very precise recipe, making it very easy to develop generic versions that have the same intended pharmacological effects as the original. Unlike small-molecule drugs, biological compounds are exceptionally difficult, if not impossible, to replicate. 

In addition to containing highly intricate molecular structures, each compound is extremely sensitive to minor alterations in the manufacturing process.  Slight differences in biological origin, manufacturing process, or molecular structure can significantly affect its safety and effectiveness. Today, scientists are working to create almost identical copies of these biologics, making them available to more people at a lower cost.  But again, there are no exact copies or “generic” biological drugs. They can only be “similar.”

Safety is an obvious issue, and there is currently no appropriate regulatory pathway for testing and approving follow-on biologics, also known as biosimilars. Follow-on biologics should not be deemed interchangeable with the original biologic the same way that a traditional generic drug is interchangeable with its brand-name counterpart. Premature action by the FDA or incomplete legislation by Congress could have serious ramifications on patient safety.

A patient taking a branded prescription chemical drug can, after careful consultation with their doctor, sometimes safely switch to a less expensive and equally effective generic drug.  The same cannot be said for patients taking brand name biologic drugs; because an adequate approval process is not in place that ensures that the biosimilars are safe.

The prospect of untested biosimilar drugs being given to patients (often without their knowledge) is a reality.  Some in the medical community fear that the Food and Drug Administration may be on the verge of approving a biosimilar version of a complex medication used to prevent blood clots in patients without adequate clinical testing. 

Ensuring patients at risk for blood clots get the best possible and safest medication is critical, and explains why, just the other day, a group of scientists, doctors and patients who represent people with clotting disorders issued a formal statement in a large national newspaper highlighting these concerns.

There is no doubt that reducing drug costs is critical for older Americans and must remain a priority for the Obama Administration, the Congress and the FDA.  However, it is also critical that any biosimilar drugs that may be used are proven just as safe as the brand name versions.  Proper testing can ensure the safety of biosimilar drugs, and older Americans should demand nothing less. The FDA should only approve drugs which have been proven, through extensive testing, to be safe.  Our lives depend on it.

RetireSafe is a grassroots advocacy and educational organization dedicated to preserving the options and protecting the benefits of America’s seniors.

 

 

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