Playing Fast and Furious with Drugs

President Obama is aggravating the drug shortage.

The President is siccing his always trustworthy and ever-so competent Attorney General Eric Holder on the pharmaceutical industry.

With an Executive Order, Obama assigned the Justice Department to “undertake whatever enforcement deems appropriate” to regulate the supply of medications. In other words, the industry is seen as guilty unless proven innocent.

From time to time, some medicines have been in short supply for medical caregivers and patients. Treatments for cancer, infections, cardiovascular troubles, and central nervous system problems are particularly in short supply currently.

With a flurry of activity and press coverage to indicate Obama is trying to show he cares that patients shouldn’t die waiting for drugs that could prolong their lives, “the Executive Order, however, “will aggravate the conditions causing the shortage,” The American Spectator reported Nov. 4.

Obama’s Executive Order tells the Food and Drug Administration (FDA) to look for potential drug shortages and the Justice Department to seek out possible collusion or price gouging (which Obama always suspects from the private sector).

In other words, pharmaceutical companies will be “suspected of criminal activity if they work together or raise prices in ways that—to FDA or DOJ lawyers—seem illegal,” the article added.

Meanwhile, shockingly, the government is buying for $433 million an experimental smallpox drug from a major donor to Democrats and Obama at a time when we face the shortage of cancer-fighting drugs.

The beneficiary of the smallpox deal is Ronald Perelman, a billionaire controlling shareholder of Siga Technologies, Inc., which makes the experimental drug.

As much as Obama wants to keep campaign money rolling in, the plan to buy an experimental smallpox drug makes absolutely no sense. Smallpox was eradicated in 1978 and is known to exist only in locked freezers in the U.S. and Russia. There’s no credible evidence, according to a Los Angeles Times story Nov. 13 that any other country or terrorist group has smallpox to use as a weapon.

If such an attack should occur, the story said, “the government could draw on $1 billion worth of smallpox vaccine it already owns to inoculate the entire U.S. population.” The vaccine costs the government $3 a dose and can prevent any fatalities.

As for current drug shortages, a report issued Nov. 14 said that most of the drug shortages are in four key areas. “Supplies of other scarce drugs are either stable or have improved, according to the IMS Institute for Healthcare Informatics, a global research organization.

The drug shortage problem is highly concentrated. More than 80 percent of the products are generics and injectables, the study said. “While representing a small part of the overall medicines market, affected products include critical drugs to treat cancer, infection, cardiovascular disease, central nervous system conditions, and pain.” The study also said “Total supply volume for many impacted products has been stable or growing.”

The IMS Institute determined that of drugs believed to be scarce, manufacturers reported stable supplies of 56 drugs and increasing availability of 31 drugs, but 75 products have declined in the past five years.

Reasons for shortages, the IMS study found included manufacturing problems, discontinuations and suspensions of production, inability to meet demand, raw material problems, and contamination or other quality issues. Some drugs are still awaiting FDA approval. There is a misconception that the main problem is older unprofitable generics. The IMS study pinpointed manufacturing problems to be the main reason for shortages.

If companies were allowed to pool resources, (and not be charged with collusion) the production times and costs could go down.

In Obama’s fiscal year budget for 2012, he called for a period of seven years during which drug manufacturers could exclusively market brand-name “biological” drugs, down from 12 years. This would give a drug company less time to have its brand-name drug exclusively on the market. It might not recover in profits the heavy expense of making and marketing that drug before a generic drug company could begin making and selling the drug.

Most biological drugs, as contrasted to chemically synthesized drugs are complex mixtures that are not easily characterized. Biological products, including those manufactured by biotechnology, are considered drugs of the future. Vaccines, gene therapy or living cells may be used to treat manufacturing steps, in contrast to most conventional drugs.

Biological products often represent the cutting-edge of biomedical research and, in time, may offer the most effective means to treat a variety of medical illnesses and conditions that presently have no other treatments available. Biological medicines cost more because they are more expensive to manufacture. But they lead to quicker recovery time.

The Department of Health and Human Services (HHS) wants all drugs to be generics because they are cheaper. But only about half the drugs on the market have a generic equivalent.

The Pharmaceutical Research and Manufacturers of America (PhRMA) representing the country’s leading pharmaceutical research and biotechnology companies, sent me a statement Nov. 22 saying it has “long worked to prevent drug shortages in advance, and will continue to work closely with the FDA to prevent manufacturing disruptions.

“The implementation of the President’s Executive Order must effectively strike a balance between addressing a complex set of rare but nevertheless concerning issues in the manufacturing process while promoting a market environment that fosters accessibility for these needed products.  Addressing anticipated occurrences of a drug shortage early in the process helps both health care providers and manufacturers identify treatment alternatives more efficiently, and we will continue to work with FDA to improve upon existing reporting requirements.

“Additionally, price gouging by secondary wholesalers is unacceptable. The ‘gray market’ presents serious concerns for patient safety as it cannot be assured that these products obtained by providers in his manner have been handled in a way that maintains produce integrity.

“While the majority of drug shortages involve generic drugs, with FDA specifically referring to an increase in shortages among ‘older sterile injectable drugs,’ this problem concerns us all and requires our combined attention.

“In the instance a shortage is anticipated, an innovator or generic manufacturer is encouraged to notify the FDA in order to address, avert and mitigate drug shortages. In the event there is a discontinuation of sole source, medically necessary drugs, companies are required to inform FDA six months in advance. Manufacturers have stepped up the voluntary reporting of anticipated events that might lead to drug shortages, and according to the FDA, in 2011, this early notification helped prevent over 99 shortages....

“It is critical that we seek a more comprehensive understanding of the many circumstances that can lead to a drug shortage as industry, Congress, FDA, patients, providers and other stakeholders try to identify meaningful ways to help alleviate, mitigate and address this critical problem. PhRMA and its members have worked — and will continue to work — diligently to this common goal.”

“PhRMA companies are leading the way in the search for new cures. PhRMA members alone invested an estimated $49.4 billion in 2010 in discovering and developing new medicines.

What we don’t need are experimental drugs Obama buys to encourage contributions to his campaign money pot.

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