Playing Fast and Furious with Drugs

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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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  • Amused

    Tait you are sooooo uninformed [ or deceptive ] on this subject , that your article is nothing more than a partisan comic book .
    There is no law , especially on the internet against grossly misinforming readers …..but there IS Karma Tait ….better lookout dude , you're no exception .

    • radicalconservative

      Ok amused, state your case. You didn’t refute (because you can’t) anything stated in the article. Buying smallpox vaccine is STUPID, and yes it is an Obama donor who stands to profit.

      • Ken

        Here, here, Radical!!!

    • Barry

      Karma? Then watch yourself, that typing finger is about to be broken.

  • larry

    Obama does these things right out in the open for people to see and nothing is ever done. A lot of time no effort is made to even hide it. It's like this administration is saying to the people "we are going to do this and there is nothing you can do about it." In the health program they bribed two senators to get the votes they needed to pass Obamacare. They did it right out in the open for everyone to see and nothing was done. I think Obama can do anything he wants and nothing will happen to him. I do not know what happened to the citizens of the United States but unless this is changed this country is doomed.

  • larry

    Congress may as well not be there. Obama doesn't pay any attention to them, he just uses and exicutive order to go around them. He knows he cannot make laws , only the legislative branch can, but he is taking the authority to do things he legally can't do and no one is doing anything about it. He was waiting until the congress was out of session and them appointing whoever he wanted to positions in the government. This administration is the most deseptive administration there has ever been and people are letting them get away with it.

  • kateyleigh

    A smallpox drug, hm? Expecting a smallpox outbreak, are we?

  • Rifleman

    Hussein's handler Jarret did say they'd "be ready to rule on day one."

    As always with government interference with a market, expect prices to go up, and availability to go down.

  • American Thinker

    Time to get rid of this clown and his puppets. Nov. 2012 is coming!

  • RxPC

    For a better discussion of the impact of drug shortages today, see the recommendations of the drug shortage summit by the ASHP (American Society of Health System Pharmacists). http://www.ashp.org/drugshortages/summitreport.
    Contrary to the assertions in this article, the shortages have been numerous, and have sent hospitals scrambling to find alternative therapies while maintaining safety, quality, and efficacy. The impact has been greatest on medications for the treatment of the most seriously ill, including chemotherapy, anesthesia agents, and drugs used in advanced cardiac life support. While we may not agree with the ASHP on the best method for managing and avoiding drug shortages, we can at least acknowledge that this has become a serious problem.

  • Dee_L

    While I agree with you on the drug shortage issue. I strongly disagree on the issue of the smallpox antiviral procurement.

    The contract was always open to competition with the "winner" the sole source supplier. There were several attempts by HHS to determine a qualifying firm. Following a rigorous process involving two competing firms it was determined Siga's drug best met all the criteria. The loser is now very ticked off and has some serious GOP political clout behind it. Would this still be an issue if the competitor didn't have a beef? Would procurement negotiations from other companies hold up to the same scrutiny?

    This process actually began under the Bush administration when funds were given to Siga to develop the drug in question. The program that fostered development of Siga's drug, as well as drugs from many other smaller biotechs, was created in 2004. It is called project Bioshield and was funded with $5.8 billion to develop and procure medical countermeasures against likely agents that could be used in a bioterrorism attack.
    The CDC considers just one case of smallpox to be a national emergency and cleanup would be economically devastating.

    Also to clarify, this is an antiviral and not a vaccine. Big difference. This is a cure. Think of it like Tamiflu vs. a flu vaccine.

    An antiviral is needed for several reasons. While smallpox was eradicated, anyone with a basic biology degree can reverse engineer the virus from existing pox viruses. It can also be synthesized, which could mean existing vaccines would be ineffective. Smallpox in its early stages mimics cold/flu-like symptoms, meaning many would be diagnosed to late to administer the vaccine. The vaccine only has a four to seven day window after exposure. Not every person can tolerate the vaccine. About 20 to 25% of the population cannot be vaccinated due to a variety of health issues. Vaccines are also known to have serious side effects even in the healthy. There are also people that are vehemently anti vaccine and will refuse vaccination.

    Will the drug work? Interesting note is Siga's product was used successfully in three cases where the vaccine caused serious illness.

    Perleman donates to both parties. Look at the whole Board of Directors. It may surprise you that not long after Stern was appointed, Frances Townsend, Homeland Security Advisor to President Bush, was added.

    The better story is: why is SIGA ‘s competitor with an inferior product and Republican backing allowed to stall this purchase for years and keep a life saving drug from the American public. On Sept.10, 2001 nobody thought the next day that planes would be used as bombs. Let’s not let politics and another failure of imagination put us in harms way again. Especially when we have the means to prevent an outbreak.