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Are all "new" meds just old drugs in new packaging?

A study by the National Institute for Health Care Management (NIHCM) Foundation claims many of the “new” medications available at our pharmacies are simply old drugs in new packaging.

NIHCM claims two-thirds of the prescription drugs approved by the Food and Drug Administration (FDA) between 1989 and 2000 were modified versions of existing medicines or identical to drugs already on the market. 

NIHCM researchers also claim the bulk of the increase in spending on new prescription drugs between 1995 and 2000 was on medicines the FDA did not designate as a priority for review.

"Highly innovative drugs are rare," says Nancy Chockley, president of the NIHCM Foundation.  "This does not mean that many of the incrementally modified and improved drugs the FDA approves don't benefit patients.  Some are of enormous benefit.  But our findings, based on the FDA's own classification systems, puts into perspective the dynamics of pharmaceutical innovation.  The plain fact is that many new drugs are altered or slightly changed versions of existing drugs, and they may or may not be all that much better than what's already available.  Consumers should be more aware of that."

The study found that as the 1990s progressed, the number of modified drugs the FDA approved grew at a faster pace than drugs based on new molecular structures.  

The study also examined trends in pharmaceutical spending on innovative versus incrementally modified drugs from 1995 to 2000.  In the retail marketplace, spending on prescription drugs doubled from $64.6 billion in 1995 to $132 billion in 2000. Of this $67.4 billion increase, $44 billion can be attributed to increased spending on drugs approved by the FDA between 1995 and 2000.  Increased spending on standard-rated medicines accounted for 67 percent ($29.3 billion) of that increase.  Increased spending on priority-rated drugs with new chemical ingredients accounted for 33 percent ($14.7 billion) of the increase.

The study found new drugs of all types were priced much higher than the older drugs they replaced

NIHCM says by modifying older medications, drug companies can extend intellectual property protection on the products. Such extensions, in turn, enable drug companies to delay generic competitors and maintain a high price for an aging product.

Drug companies fire back

The Pharmaceutical Research and Manufacturers Association (PhRMA) quickly criticized the NIHCM study.

PhRMA argues the research and development of a drug is a long, risky and expensive process. The association claims many people are surprised to learn that:

  • According to the Tufts Center for the Study of Drug Development, it takes about $800 million to bring just one new drug to patients.
  • Researchers spend 10-15 years developing and testing a medicine before it receives FDA approval.
  • Most medicines fail in laboratory testing. For example, of the 10,000-15,000 compounds screened in the lab, only one ever gets to the medicine chest.

PhRMA also denies it’s more interested in keeping patents on existing drugs, than spending the money to develop new medications.

PhRMA claims pharmaceutical companies have made numerous breakthroughs in recent years, including:

  • protease inhibitors that have given many AIDS patients a future;
  • a drug that can prevent debilitating brain damage from strokes;
  • drugs that prevent nausea in chemotherapy patients;
  • drugs that lessen the severity and frequency of Multiple Sclerosis attacks.

PhRMA also claims many new drugs are vastly superior to older, cheaper medications used to treat similar conditions.  The association says the new drugs might have different side effect profiles, for example, and thus be better for some patients.

PhRMA argues since no two individuals are alike, it's good for doctors to have a variety of medicines available to treat the same condition. PhRMA contends most patients and doctors appreciate having the choice.

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