RegBits: 5 Things to Know About Healthcare Product Regulation Today (12 September 2014)

Posted 12 September 2014 | By Alexander Gaffney, RAC 

RegBits: 5 Things to Know About Healthcare Product Regulation Today (12 September 2014)

Welcome to RegBits, a new way to get an at-a-glance look at important regulatory news stories. Today's top stories include pressure on FDA to overturn its ban on certain blood donations, the Senate's attempt to overhaul the Time-and-Extent Application process, new problems for Indian drug manufacturers, a look at the advantages of being the first drug to clear FDA's regulatory hurdles, and new classifications for several device classes.

Senators Call for Reversal of Gay Blood Donor Ban

Though it seems to happen every year, legislators are once again calling on the US Food and Drug Administration (FDA) and the US Department of Health and Human Services (DHHS) to overturn a longtime ban on the donation of blood by men who have had sex with men.

DHHS has been re-evaluating its stance on the policy, which has been in place since 1977, since at least March of 2012, when it said it would be soliciting new comments on the issue. According to an August 2014 report by MedPage Today, FDA and DHHS have recently completed studies on the issue and are now "in the process of evaluating the data to determine if a change in policy should be considered."

Now, several US senators are weighing in on the issue and calling for FDA to overturn its ban. In a letter to DHHS Secretary Sylvia Burwell on 8 September 2014, five legislators said FDA's current policy "fails[s] to reflect the advances in HIV detection and the scientific community's understanding of the virus since the policy was first established."

The policies also serve to "perpetuate inaccurate stereotypes, promote discrimination, and discourage individuals from seeking other appropriate health services," the legislators said. "It is time that the agency took action, and we encourage such action to also address the deficiencies of the tissue donation policy.”

(Letter) (Press)

Sunscreen Innovation Act Approaches Next Hurdle

The US Senate's Health, Education, Labor and Pensions (HELP) Committee is preparing to vote on the passage of the Sunscreen Innovation Act, a bill which seeks to overhaul the Time and Extent Application (TEA) process and remove barriers which have long delayed the approval of sunscreen ingredients which have long been marketed outside the US.

The bill has already seen passage in the US House of Representatives, and enjoys broad support in the Senate as well. However, the Senate version of the bill has major differences than its House counterpart which could slow down the approval of the bill. As opposed to the House, the Senate version of the bill seeks to overhaul the entire TEA process, as opposed to focusing on just sunscreen ingredients.

The HELP Committee will meet on 17 September 2014 to vote on the bill. If passed by the full Senate, the bill will go to a conference committee between the House and Senate to resolve differences in the bill.

(Senate HELP Committee Notice)

More Problems for Indian Drug Manufacturers

A new study issued this week in the National Bureau of Economic Research (NBER) looks at the quality of 1,470 antibiotic and tuberculosis drug samples made in India and marketed in Africa and India.

The study, led by Roger Bate, found that 10.9% of the drugs tested failed to contain the correct active pharmaceutical ingredients, while an additional 7% were substandard (e.g. contained the right API but the wrong amount).

The paper concludes, "One likely explanation is that Indian pharmaceutical firms and/or their export intermediaries do indeed differentiate drug quality according to the destination of consumption."


Is it Better to be First or Best?

Is there an advantage to being first to market with a new drug? Yes, but the benefit may be smaller than most companies realize, claims in a new report by McKinsey & Company.

In its September 2014 issue, the consultancy looked at 492 drug launches between 1986 and 2012. The analysis showed that first-to-market products enjoyed a 40% market share 10 years after launch, but that second-to-market drugs enjoyed a 33% share of the market. Third-to-market drugs had a larger drop-off, commanding just 19% of the market 10 years after the launch of its first competitor.

The paper has two conclusions: "First, the value of being first should not be overestimated, particularly when the lead time is short (less than two years) and a market is expected to be crowded with more than two players. Second, while first-mover advantage can be difficult to surmount when it comes to well-resourced and experienced players with long lead times, being first isn’t always as important as being best."


Device Reclassification Mania

FDA has reclassified three medical devices this week, including:

As Class II devices subject to special controls, device companies can develop the products using the premarket notification [510(k)] pathway instead of the more rigorous premarket approval (PMA) pathway.

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