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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