New “21st Century Cures” Bill Gives More Power to Pharmaceutical Industry

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It’s called a 21st century bill, but this extraordinarily dense legislative proposal follows an old, 20th century paradigm: if there’s an illness, create some new government-subsidized drugs to throw at it. Action Alert!

The “21st Century Cures Act” is close to 400 pages long. If enacted, it would dramatically alter the ways pharmaceutical and medical device products are regulated in the US.

The bill has not yet been introduced, but has broad support in the Republican-controlled House Energy and Commerce Committee. It appeared that committee chair Fred Upton (R-MI) had broad bipartisan backing until his lead collaborators, Rep. Diana DeGette (D-CO) and ranking memberRep. Frank Pallone (D-NJ), pulled their support. DeGette did not give a reason for her withdrawal; Pallone stated it was because the proposal creates more problems in the healthcare system than it solves, and that the draft bill does not include “any real dollars to fund additional basic research at the NIH.”

We are opposed to the bill as it stands and are working with Energy and Commerce to see if our major concerns can be addressed. Although its stated purpose is to modernize medicine, it is mostly focused on streamlining the drug approval process and extending market exclusivity (and therefore profits) for drugs. In other words, it basically throws more money at an old system, while expecting things to change. This is a 20th century paradigm, not a 21st century one.

Market exclusivity for drugs is a major part of the problem in healthcare today and especially the cost of healthcare. Giving drug companies even more years of government enforced monopoly is no solution.

Market Exclusivity

This bill would create a fifteen-year market exclusivity for what are called specialty drugs—that is, drugs for which there is deemed to be an unmet medical need, usually due to the complexity or limited extent of the disease. By contrast, current market exclusivity is five years for conventional drugs and twelve years for specialty drugs. This is after FDA approval and is on top of the grant of government monopoly conferred by the patent. If you wonder why medicine costs so much, stop right here. Government both enforces drug monopolies and also ensures that medicine will be dominated by drugs. Natural therapies are quashed by issuing gag orders on producers of them.You won’t be surprised to learn that more and more drug applications to the FDA by drug companies are for drugs that are characterized as specialty drugs. Who wants to submit a drug that gets five years of monopoly when by tweaking the name you can get twelve years?

The bill would also extend exclusivity for two years for significant improvements to existing drug molecules. This might include developing new delivery systems, new drug combinations, or new formulations that lead to fewer adverse events. You can be sure that this will result in drug companies changing a drug ever so slightly, with very little added benefit, just to extend exclusivity, with a wink and a nod from regulators. Very few completely new drugs have been introduced in recent years; they are usually variations of old drugs, and this bill would only exacerbate that trend.
If the pharmaceutical company can show that an existing drug can also treat a rare medical condition (an “orphan disease,” that is, one that affects only a small percentage of the population), the drug will then be known as an “orphan drug,” and the company will gain an additional six months of market exclusivity.

Antibiotics

The bill establishes a new designation for antibacterial drugs: “Qualified Infectious Disease Products.” These are drugs that treat pathogens which have the “potential to pose a serious threat to public health.” These drugs will receive, under this bill, an additional five years of market exclusivity. Outrageously, companies can transfer up to twelve months of that exclusivityto “one or more drugs”!
Approval for new antibiotics would also be streamlined—but with no discussion about investigating the natural alternatives that already exist. These include silver, intravenous vitamin C, the herbs cat’s claw and artemisia, some essential oils, grapefruit seed extract, or hyperbaric oxygen therapy.
While it charges the CDC to monitor any overuse of antibiotics, the bill fails to give specific guidance about common routes of exposure such antibiotics in animal feed. In fact, there is no mention whatsoever in this massive document of antibiotics in meat.

Immunization

The bill charges the Centers for Disease Control and Prevention (CDC) to conduct a review of Advisory Committee on Immunization practices—specifically with regard to the transparency and consistency of its procedures in formulating and issuing vaccine recommendations. One change we would like to see in this area is to ask the government, as part of any such process, to investigate all adverse event report (AER) data as well. As we reported previously, the government currently refuses to look at AERs, taking the position that correlation does not equal causation. We believe the data raises some serious red flags that need to be investigated thoroughly.
There is also an expedited review and approval process for “breakthrough vaccines,” especially in the face of public health crises, but it doesn’t put important safeguards in place to protect the public, such as informed consent or post-market studies.

Chronic Diseases

The Department of Health and Human Services (HHS) would have to develop and carry out alongitudinal study to help patients with chronic diseases. This may sound good, but we’re concerned that the committee in charge will not include input from integrative doctors, nutritionists, and others in the integrative medical community. True chronic disease prevention needs to include lifestyle and nutrition factors, including dietary supplements. Nor do we think that solutions are likely to come from a government committee that will inevitably be heavily influenced by special interests.

This is a huge bill, one whose depths we have not yet fully plumbed. We will, as always, keep you posted on new developments as the bill is introduced and makes its way through Congress. Be prepared for some major opportunities to make your voice heard!

Action Alert! Since the bill hasn’t yet been formally introduced, now is the best time to amend the language. This bill is expected to move quickly, so it is essential that we express all of our concerns now. Write your senators and representative, explain your problems with the bill, and ask them to amend it before it’s introduced. Please take action immediately!