Should there be a

Public Domain Drug Act?

We are denied access to many great treatments because our government does not have a system for the for the approval of unpatentable drugs

Drugs in the public domain should be sponsored by public money

The Current System:

There is no system in place for the approval of unpatentable drugs such as DCA. The federal drug approval program, run by the FDA, depends on patents. The new drug approval process is very costly, running from hundreds of millions to over a billion dollars. If a company cannot own the full rights to a molecule, they will not spend the money.

In 1983 the US passed the Orphan Drug Act (FDA link) to encourage development of drugs for rare diseases. The Orphan Drug Act also depends upon patent protection, and that protection is often extended by the granting of "marketing exclusivity" by the FDA. Additionally companies can receive tax credits and research grants. The passage of the Orphan Drug Act has resulted in the marketing approval of several hundred orphan drugs, some of which exceed $200,000 and even $300,000 a year.

Generic drug approval depends upon data submitted with the original application for the drug. Generic drugs are patented drugs that have lost patent protection. DCA and other unpatentable drugs do not fit here as there is no data submitted.

One standard technique used by pharmaceutical companies is the development of "derivatives", in which a great naturally occurring compound is altered to make it unique and patentable. That work-around does not always work though. For example, with DCA, what can you do? It is so simple, so tiny, there are no options available. And why should we ignore a low cost, safe and effective compound just because nobody can patent it?

Unpatentable Drugs have no home at the FDA

Public domain, unpatentable material, such as DCA, that are found to have potential as a new therapy have no place in the FDA approval process. No system exists, there is no money available, and there will be no corporate sponsor for attempting approval.

A solution

If a drug is in the private domain, fully patentable, then the research is paid for by the owner of that drug.

If the drug is owned by the people, then the people should have a right to examine its potential and attempt approval. Tax money should be spent on the necessary testing. If the drug is approved for use, it should automatically qualify as a generic drug.

Why should we be denied access to life saving drugs because our country does not have laws to handle the problem?

Should we push for the development and passage of a "Public Domain Drug Act"?

Comments and Alternatives

"But wait", a critic might say. "Why should the government spend money on drug research? Why should we place the government in competition with private enterprise?"

Look at the money:

The FDA takes great pride in showing us how much money we save from having generic drugs available: The FDA states we save $10 billion dollars a year because generic drugs are available. We'd save much more if these unpatentable drugs were available.

Currently orphan drugs manufacturers get tax breaks, research grants and can charge seriously high prices. All of that costs us, the people. We are paying for this drug development via corporate incentives. If we can pay for orphan drug development, then we can pay for unpatentable, public domain drugs to be developed.

Look at the options:

There is no system in place.

One suggestion is the awarding and enforcement of a lengthy exclusivity period by the FDA.

Something MUST be done. It is immoral for our legislators to deny us access to these treatments. Profit should not trump life. Can we allow special interest money to block legislation? The pharmaceutical lobby is the largest in Washington D.C. and can get whatever it wants.

There is a growing gap in the drug approval process, as more and more unpatentable compounds are discovered to have great health benefits, and at very low cost. It is our government, and our lives. It is our right to have access to treatments, whether or not they are profitable to corporations. If a drug is owned by the people, in the public domain, then the people have a right to it. We need a Public Domain Drug Act.

In lieu of a federal action, we have one other recourse: state propositions. If the voters of 13 states could approve marijuana for medicinal use, then the voters should be willing to approve unpatentable drugs, especially for the terminally ill.

Federal action is preferred. Our law makers are supposed to be listening and working for us, the people. People vote, not corporations. People should not have to suffer because of a gap in the drug approval process.