We face a crisis of drug shortages. Some hospital patients now have to take medications that aren’t effective. For others, treatment is dangerously delayed. Life-saving or life-prolonging medicines are increasingly in short supply for the one in ten Americans hospitalized on any particular day.
The Obama Administration is partly to blame. The crisis may worsen as the ObamaCare bureaucracy controls all aspects of health care in America.
A new survey released by the American Hospital Association (AHA) with responses from 820 facilities across the country reveals “serious consequences for patient care and access to vital therapies.”
With increasing frequency of drug shortages, the AHA survey revealed that “almost 100 percent of hospitals reported a shortage in the last six months and nearly half of the hospitals reported 21 or more drug shortages.”
Some hospitals were able to find alternative sources for drugs in short supply. But:
“The number of drugs in short supply is increase at an alarming rate and hospitals are working diligently to reduce the impact on the patients they care for,” said AHA President and CEO Rich Umbdenstock.
The American Society of Health-System Pharmacists (ASHP) conducted a survey as well, with the University of Michigan Health System. It found that labor costs and time needed to manage shortages are significant—estimated at an annual financial impact of $216 million nationally.
What has Obama to do with this disturbing health crisis? In his 2012 budget, Obama called for cutting the number of years drug makers could exclusively market brand-name biologic drugs to 7 years from 12 years. This means drug companies would have less time to profit from a new drug. So, they may not spend the $1 billion or more to make the drug.
Obama also wants to end “pay-for-delay” deals that affect traditional, “chemical” drugs by giving the Federal Trade Commission the power to block the deals. “Under such pacts,” as a story in Reuters explains, “brand-name and generic drug makers settle patent challenges with payoffs that delay lower-cost rivals from reaching the market.” Both brand and generic drug industries want to preserve the pay-to-delay settlements. Preserving the delays keeps the current manufacturers viable and continuing to supply needed drugs to the market on a regular basis.
Biologic drugs—which Obama indirectly wants to restrict–are called the drugs of the future. They may be a vaccine, blood component, allergenic, somatic cell, gene therapy, tissue, recombinant therapeutic protein, or living cell used to treat diseases. Gene-based and cellular biologics are often at the forefront of medical research and can be used to treat a breadth of medical problems when no other treatments are available.
Biologic medicines cost much more than ordinary drugs. They are much more expensive to manufacture. They also are proving to have better long-term outcomes with fewer side effects. Studies show “this leads to quicker recovery time and less additional treatment,” according to Consumer Health Information Corp.
Obama and his co-conspirators at the Department of Health and Human Services (HEW) have been seeking–with the determination of a lion in a death chase after a zebra–to make all medicines generic because they are cheaper and could save money to spend elsewhere in the overly costly ObamaCare fiasco.
The Reuters article said HEW Secretary Sebelius “was unapologetic about the extra savings” to help cover other health costs. The two Administration proposals to get cheaper generics were said to save $11 billion over 10 years.
But there’s a sizeable catch: only about half of the brand-name drugs on the market today have a generic equivalent. Some drugs also are protected by patents and are supplied by only one company. So, Sebelius or anybody else will never be able to replace all brand medicines with generics.
An FDA press release on drug shortages said the agency “works with other firms who manufacture the drug, asking them to ramp up production if possible to prevent or mitigate a shortage. FDA encourages reporting shortages, and companies voluntarily provide shortage information. But they are not required to do so unless the drug manufacturer is the sole maker of a drug that’s “medically necessary.”
In the report of a meeting last year of the American Society of Health System Pharmacists, participants also touched on the ethical dilemma they face in having to prioritize use of any remaining stock of drugs involved in a shortage. Who gets
the desirable medication, and who gets what may be a less desirable alternative drug? The stress of making such decisions can be seen in the brutally honest and emotional responses from survey participants. As noted by one respondent, when a suitable alternative for a lifesaving drug is no longer available, “I guess patients just have to die.” Another respondent asked, “What do I tell our breast and lymphoma patients? You had a curable disease but not anymore because there is no drug available?”
The FDA announced Aug. 9 it was holding a meeting September 26 of industry and consumer groups to discuss reducing the drug shortage. The agency could expedite the approval process for new drugs, as has long been sought by pharmaceutical manufacturers.
But undoubtedly most effective would be a realistic posture by the Obama Administration that it not only can’t control all health problems, but also that it doesn’t even know such facts as: for some drugs there are no cost-effective generic versions.